Arikace™    (DrugBank: -)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症37

299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162
Searched query = "Cystic fibrosis"
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.
37 / 1,592 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-000443-24-NL
(EUCTR)
25/04/201306/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
2EUCTR2011-000443-24-DK
(EUCTR)
14/12/201222/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
3NCT01316276
(ClinicalTrials.gov)
October 5, 201214/3/2011Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) InfectionLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaCystic FibrosisDrug: Liposomal amikacin for inhalationInsmed IncorporatedNULLCompleted6 YearsN/AAll206Phase 3Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;United Kingdom
4EUCTR2011-000441-20-NL
(EUCTR)
11/09/201206/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom
5EUCTR2011-000441-20-BG
(EUCTR)
13/06/201203/05/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-000443-24-SE
(EUCTR)
24/05/201207/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
7EUCTR2011-000441-20-IE
(EUCTR)
02/05/201226/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Code: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
8EUCTR2011-000443-24-IT
(EUCTR)
10/04/201219/03/2012Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
250Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
9EUCTR2011-000441-20-DK
(EUCTR)
29/03/201222/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
10NCT01315691
(ClinicalTrials.gov)
February 29, 201214/3/2011Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas AeruginosaRandomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaCystic FibrosisDrug: Liposomal amikacin for inhalation;Drug: Placebo for liposomal amikacin for inhalationInsmed IncorporatedNULLWithdrawn6 YearsN/AAll0Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-000443-24-BE
(EUCTR)
30/01/201225/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
12EUCTR2011-000441-20-BE
(EUCTR)
30/01/201225/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
Product Code: N/A
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany
13EUCTR2011-000443-24-PL
(EUCTR)
20/01/201206/10/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
14EUCTR2011-000443-24-DE
(EUCTR)
11/10/201130/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
15EUCTR2011-000442-38-BG
(EUCTR)
03/10/201105/07/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2011-000443-24-BG
(EUCTR)
03/10/201128/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
17EUCTR2011-000441-20-IT
(EUCTR)
01/10/201108/03/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: Tobi
INN or Proposed INN: TOBRAMYCIN
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy
18EUCTR2011-000442-38-ES
(EUCTR)
21/09/201111/11/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden
19EUCTR2011-000441-20-DE
(EUCTR)
19/09/201130/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
20EUCTR2011-000443-24-GR
(EUCTR)
09/08/201123/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-000443-24-IE
(EUCTR)
05/08/201126/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
22EUCTR2011-000443-24-GB
(EUCTR)
03/08/201124/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
23EUCTR2011-000441-20-GB
(EUCTR)
03/08/201124/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
24EUCTR2011-000443-24-FR
(EUCTR)
28/07/201131/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
25EUCTR2011-000443-24-AT
(EUCTR)
22/07/201127/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-000441-20-AT
(EUCTR)
19/07/201121/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
27EUCTR2011-000441-20-GR
(EUCTR)
15/07/201122/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
28EUCTR2011-000443-24-SK
(EUCTR)
04/07/201120/02/2014Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands
29EUCTR2011-000441-20-SK
(EUCTR)
04/07/201125/11/2014Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
30EUCTR2011-000443-24-HU
(EUCTR)
29/06/201111/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-000441-20-HU
(EUCTR)
29/06/201120/04/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
32EUCTR2006-006980-22-BE
(EUCTR)
27/06/200719/07/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin sulfate
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Hungary;Belgium
33EUCTR2006-006980-22-HU
(EUCTR)
14/06/200703/04/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Hungary;Belgium
34EUCTR2006-006980-22-SK
(EUCTR)
17/05/200723/04/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Transave, Inc.NULLNot Recruiting Female: yes
Male: yes
60Phase 2Hungary;Slovakia;Poland;Belgium
35NCT00777296
(ClinicalTrials.gov)
February 22, 200715/10/2008Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)Phase 2a Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) In Cystic Fibrosis Patients With Chronic Infections Due To Pseudomonas Aeruginosa.Cystic FibrosisDrug: ARIKACE™;Drug: PlaceboInsmed IncorporatedNULLCompleted6 YearsN/AAll66Phase 1;Phase 2Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Bulgaria;Macedonia, The Former Yugoslav Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2006-006980-22-PL
(EUCTR)
22/08/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Slovakia;Belgium;Poland
37EUCTR2011-000442-38-PL
(EUCTR)
01/08/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden