Preladenant    (DrugBank: Preladenant)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病47

6. パーキンソン病 [臨床試験数:2,123,薬物数:2,046(DrugBank:324),標的遺伝子数:183,標的パスウェイ数:198
Searched query = "Parkinson disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
47 / 2,123 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000025638
2016/11/0116/01/2017Adenosine A2A receptors in Parkinson's disease Parkinson's disease11C-preladenant-PET scanningTokyo Metropolitan Institute of GerontologyNULLComplete: follow-up complete40years-old89years-oldMale and Female40Not selectedJapan
2EUCTR2009-015162-57-NL
(EUCTR)
21/11/201111/05/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme corp.NULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
3EUCTR2009-015162-57-PT
(EUCTR)
04/11/201112/08/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
4EUCTR2009-015162-57-PL
(EUCTR)
25/10/201130/08/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
5EUCTR2009-015162-57-IT
(EUCTR)
22/09/201127/04/2011A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - NDA Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - ND Parkinson`s disease
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Preladenant
Product Code: SCH420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
INN or Proposed INN: Rasagiline
Schering-Plough Research Institute, division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;Czech Republic;Finland;Poland;Spain;Lithuania;Bulgaria;Netherlands;Latvia;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2009-015162-57-GB
(EUCTR)
16/08/201126/01/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
7EUCTR2009-015162-57-BG
(EUCTR)
04/08/201109/06/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
8EUCTR2009-015162-57-LT
(EUCTR)
25/07/201121/04/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
9EUCTR2009-015162-57-LV
(EUCTR)
19/07/201111/05/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153 AM1)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Serbia;Portugal;United States;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
10EUCTR2009-015162-57-SE
(EUCTR)
12/07/201131/05/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-020112-11-LT
(EUCTR)
29/06/201106/04/2011Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
585Phase 3United States;Serbia;Mexico;Argentina;Ukraine;Croatia;Lithuania;Chile;South Africa;Russian Federation;Latvia;Colombia
12EUCTR2010-020112-11-LV
(EUCTR)
21/06/201108/04/2011Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037 Parkinson's disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
585Phase 3United States;Serbia;Mexico;Argentina;Ukraine;Lithuania;Croatia;South Africa;Russian Federation;Chile;Colombia;Latvia
13EUCTR2009-015162-57-CZ
(EUCTR)
17/06/201115/04/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
14EUCTR2009-013552-72-PL
(EUCTR)
08/06/201123/02/2011A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
15EUCTR2009-015161-31-PL
(EUCTR)
08/06/201123/02/2011A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2009-015162-57-ES
(EUCTR)
23/05/201131/03/2011Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153)Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153) Enfermedad de Parkinson
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Czech Republic;Poland;Bulgaria;Latvia;Netherlands;Sweden
17EUCTR2009-015161-31-DE
(EUCTR)
04/04/201124/08/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
18NCT01323855
(ClinicalTrials.gov)
March 28, 201124/3/2011A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal ImpairmentParkinson DiseaseDrug: PreladenantMerck Sharp & Dohme Corp.NULLCompleted18 Years75 YearsAll46Phase 1Germany
19EUCTR2009-013552-72-BG
(EUCTR)
24/03/201126/01/2011A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
20EUCTR2009-015162-57-AT
(EUCTR)
17/03/201103/02/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2009-015161-31-GB
(EUCTR)
07/03/201101/07/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
22EUCTR2009-013552-72-GB
(EUCTR)
07/03/201107/07/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot Recruiting Female: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
23EUCTR2009-015162-57-FI
(EUCTR)
02/03/201120/01/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
24NCT01294800
(ClinicalTrials.gov)
February 25, 201110/2/2011A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402)Parkinson's DiseaseDrug: Preladenant;Drug: Placebo tablet to match PreladenantMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll450Phase 2Japan
25EUCTR2009-015161-31-BG
(EUCTR)
17/02/201102/02/2011A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2009-015161-31-PT
(EUCTR)
28/01/201129/10/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
27EUCTR2009-015161-31-CZ
(EUCTR)
17/01/201128/07/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
28EUCTR2009-013552-72-CZ
(EUCTR)
17/01/201128/07/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
29EUCTR2009-015161-31-NL
(EUCTR)
09/12/201009/08/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden;United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India
30EUCTR2009-013552-72-IT
(EUCTR)
06/12/201004/11/2010A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - NDA Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - ND Parkinson`s Disease
MedDRA version: 9.1;Level: PT;Classification code 10061536
Product Name: Preladenant
Product Code: SCH420814
Product Name: Preladenant
Product Code: SCH420814
Product Name: Preladenant
Product Code: SCH420814
Trade Name: Azilect
INN or Proposed INN: Rasagiline
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2009-015161-31-IT
(EUCTR)
06/12/201028/09/2010 A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND Parkinson`s Disease
MedDRA version: 9.1;Level: PT;Classification code 10061536
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;Finland;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden
32EUCTR2009-015161-31-SE
(EUCTR)
02/12/201006/10/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
33EUCTR2009-013552-72-SE
(EUCTR)
02/12/201006/10/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
34NCT01227265
(ClinicalTrials.gov)
November 19, 201022/10/2010Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)A Phase 3, 12 Week, Double-blind, Placebo-controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease.Parkinson Disease;Idiopathic Parkinson Disease;Idiopathic Parkinson's DiseaseDrug: Preladenant;Drug: PlaceboMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll476Phase 3Argentina;Chile;Colombia;Croatia;Latvia;Lithuania;Mexico;Russian Federation;Serbia;South Africa;Ukraine;United States
35NCT01215227
(ClinicalTrials.gov)
November 18, 20104/10/2010An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153)Parkinson Disease;Idiopathic Parkinson DiseaseDrug: Preladenant;Drug: Rasagiline;Drug: Placebo to preladenant;Drug: Placebo to rasagilineMerck Sharp & Dohme Corp.NULLTerminated30 Years85 YearsAll839Phase 3Argentina;Austria;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;France;India;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Sweden;Ukraine;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2009-015161-31-AT
(EUCTR)
03/11/201017/08/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
37EUCTR2009-013552-72-ES
(EUCTR)
26/10/201027/07/2010Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSEEstudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE Enfermendad de Parkinson
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Schering Corporation, división Schering-Plough ResearchNULLNot Recruiting Female: yes
Male: yes
1000Phase 3Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
38EUCTR2009-013552-72-HU
(EUCTR)
21/10/201011/08/2010A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - MonotherapyA Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - Monotherapy Parkinson's diseaseProduct Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Czech Republic;Hungary;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
39EUCTR2009-015161-31-FR
(EUCTR)
19/10/201029/07/2010A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's DiseaseA Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden
40EUCTR2009-013552-72-FI
(EUCTR)
07/09/201002/07/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2009-015161-31-FI
(EUCTR)
17/08/201023/06/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
42NCT01155466
(ClinicalTrials.gov)
July 14, 201030/6/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938)Parkinson DiseaseDrug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Placebo to Preladenant Tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo to Rasagiline capsuleMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll778Phase 3Austria;Brazil;Bulgaria;Canada;Czech Republic;Finland;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States
43NCT01155479
(ClinicalTrials.gov)
July 6, 201030/6/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's DiseaseParkinson DiseaseDrug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo for Rasagiline 1 mg capsule;Drug: Placebo for PreladenantMerck Sharp & Dohme Corp.NULLTerminated30 Years85 YearsAll1022Phase 3Argentina;Bulgaria;Canada;Chile;Colombia;Czech Republic;Finland;France;Germany;Hungary;India;Israel;Italy;Mexico;Peru;Poland;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States
44NCT00845000
(ClinicalTrials.gov)
April 21, 200913/2/2009Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated PatientsParkinson DiseaseDrug: SCH 420814 10 mg;Drug: SCH 420814 100 mg;Drug: Placebo;Drug: Levodopa;Drug: CarbidopaMerck Sharp & Dohme Corp.Oregon Health and Science UniversityCompleted18 YearsN/AAll12Phase 1United States
45NCT00537017
(ClinicalTrials.gov)
November 23, 200727/9/2007Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)Parkinson Disease;Neurodegenerative Diseases;Central Nervous System Diseases;Movement Disorders;Brain DiseasesDrug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll140Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00406029
(ClinicalTrials.gov)
November 20, 200630/11/2006Dyskinesia in Parkinson's Disease (Study P04501)A Phase 2, 12-Week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and DyskinesiasParkinson Disease;Movement Disorders;Central Nervous System Diseases;Neurodegenerative Diseases;Brain DiseasesDrug: Preladenant;Drug: Placebo;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll253Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Italy;New Zealand;Peru;Singapore;South Africa;Spain;United States
47EUCTR2009-013552-72-DE
(EUCTR)
23/08/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden