Pramipexole extended release (DrugBank: Pramipexole)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 6 | Parkinson disease | 23 |
| 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 | NCT01191944 (ClinicalTrials.gov) | August 2010 | 30/8/2010 | Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients | A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa | Parkinson Disease | Drug: pramipexole immediate release tablet;Drug: pramipexole extended release tablet | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 475 | Phase 3 | China |
| 2 | NCT01097421 (ClinicalTrials.gov) | March 2010 | 25/3/2010 | Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease | Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease | Parkinson Disease | Drug: Pramipexole Extended Release | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 329 | N/A | Sweden |
| 3 | EUCTR2007-004234-16-AT (EUCTR) | 14/04/2009 | 10/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 4 | EUCTR2007-004235-37-AT (EUCTR) | 02/04/2009 | 10/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 5 | EUCTR2007-004235-37-IT (EUCTR) | 02/10/2008 | 28/11/2007 | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Patients with advanced idiopathic PD MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 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 |
| 6 | EUCTR2007-004235-37-GB (EUCTR) | 19/08/2008 | 26/11/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 7 | EUCTR2007-004235-37-PL (EUCTR) | 29/05/2008 | 16/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden | |||
| 8 | EUCTR2007-004235-37-SE (EUCTR) | 23/04/2008 | 25/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 9 | EUCTR2007-004234-16-FI (EUCTR) | 16/04/2008 | 12/02/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 520 | Hungary;Finland;Czech Republic;Netherlands;France;Austria | |||
| 10 | EUCTR2007-004234-16-HU (EUCTR) | 17/03/2008 | 17/01/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 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 |
| 11 | EUCTR2007-004235-37-HU (EUCTR) | 17/03/2008 | 17/01/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 12 | EUCTR2007-004235-37-ES (EUCTR) | 24/01/2008 | 08/03/2010 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 13 | EUCTR2007-004235-37-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden | |||
| 14 | EUCTR2007-004234-16-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 15 | EUCTR2007-004234-16-SK (EUCTR) | 14/01/2008 | 18/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands | ||
| 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 |
| 16 | EUCTR2007-004235-37-SK (EUCTR) | 14/01/2008 | 16/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden | ||
| 17 | EUCTR2007-004234-16-FR (EUCTR) | 11/01/2008 | 19/11/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | BOEHRINGER INGELHEIM | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 18 | NCT00601523 (ClinicalTrials.gov) | January 2008 | 15/1/2008 | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). | Parkinson Disease | Drug: Placebo;Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 511 | Phase 3 | United States;Austria;Czech Republic;Finland;France;Germany;Hungary;India;Japan;Malaysia;Netherlands;Russian Federation;Slovakia;Taiwan;Ukraine;Argentina |
| 19 | NCT00577460 (ClinicalTrials.gov) | December 2007 | 19/12/2007 | Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD) | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 391 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 20 | NCT00560508 (ClinicalTrials.gov) | November 2007 | 16/11/2007 | A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period | A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER | Parkinson Disease | Drug: Pramipexole Immediate Release;Drug: Pramipexole Extended Release | Boehringer Ingelheim | NULL | Completed | 1 Year | N/A | All | 112 | Phase 2;Phase 3 | Japan |
| 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 |
| 21 | EUCTR2007-004234-16-NL (EUCTR) | 29/10/2007 | 17/10/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 22 | NCT00558025 (ClinicalTrials.gov) | October 2007 | 12/11/2007 | Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease | A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR | Parkinson Disease | Drug: Pramipexole Extended Release;Drug: Pramipexole Immediate Release | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 156 | Phase 3 | France;Germany;Netherlands |
| 23 | 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 |