DDrare: Database of Drug Development for Rare Diseases

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	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00479401 (ClinicalTrials.gov)	May 2007	25/5/2007	Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients	A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).	Early Parkinson Disease (Early PD)	Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	30 Years	N/A	All	539	Phase 3	United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil
2	NCT00466167 (ClinicalTrials.gov)	April 2007	25/4/2007	Pivotal Study in Advanced Parkinsons Disease Patients	A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).	Parkinson Disease	Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	32 Years	N/A	All	517	Phase 3	Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00479401
(ClinicalTrials.gov)

May 2007

25/5/2007

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).

Early Parkinson Disease (Early PD)

Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

30 Years

N/A

All

539

Phase 3

United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil

NCT00466167
(ClinicalTrials.gov)

April 2007

25/4/2007

Pivotal Study in Advanced Parkinsons Disease Patients

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).

Parkinson Disease

Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

32 Years

N/A

All

517

Phase 3

Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom