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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00560508 |
The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on L-DOPA therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).
Condition | Intervention | Phase |
---|---|---|
Parkinson Disease |
Drug: Pramipexol Extended Release Drug: Pramipexol Immediate Release Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole 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 |
Estimated Enrollment: | 100 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who exhibit any therapeutically problematic issues or status based on L-DOPA therapy:
Exclusion Criteria:
Japan | |
248.610.001 Boehringer Ingelheim Investigational Site | |
Bunkyo-ku, Tokyo, Japan | |
248.610.002 Boehringer Ingelheim Investigational Site | |
Takamatsu, Kagawa, Japan | |
248.610.004 Boehringer Ingelheim Investigational Site | |
Sagamihara, Kanagawa, Japan | |
248.610.005 Boehringer Ingelheim Investigational Site | |
Okayama, Okayama, Japan | |
248.610.006 Boehringer Ingelheim Investigational Site | |
Aomori, Aomori, Japan | |
248.610.020 Boehringer Ingelheim Investigational Site | |
Akita, Akita, Japan | |
248.610.021 Boehringer Ingelheim Investigational Site | |
Kyoto, Kyoto, Japan | |
248.610.003 Boehringer Ingelheim Investigational Site | |
Kodaira, Tokyo, Japan | |
248.610.012 Boehringer Ingelheim Investigational Site | |
Osaka, Osaka, Japan | |
248.610.019 Boehringer Ingelheim Investigational Site | |
Akashi, Hyogo, Japan | |
248.610.015 Boehringer Ingelheim Investigational Site | |
Iwamizawa,Hokkaido, Japan | |
248.610.007 Boehringer Ingelheim Investigational Site | |
Shiroishi, Miyagi, Japan | |
248.610.008 Boehringer Ingelheim Investigational Site | |
Kyoto, Kyoto, Japan | |
248.610.009 Boehringer Ingelheim Investigational Site | |
Shimogyo-ku, Kyoto, Kyoto, Japan | |
248.610.017 Boehringer Ingelheim Investigational Site | |
Asahikawa, Hokkaido, Japan | |
248.610.018 Boehringer Ingelheim Investigational Site | |
Asahikawa, Hokkaido, Japan | |
248.610.011 Boehringer Ingelheim Investigational Site | |
Fukuoka, Fukuoka, Japan | |
248.610.010 Boehringer Ingelheim Investigational Site | |
Morioka, Iwate, Japan | |
248.610.014 Boehringer Ingelheim Investigational Site | |
Fuchu, Tokyo, Japan |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 248.610 |
Study First Received: | November 16, 2007 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00560508 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Neurotransmitter Agents Levodopa Ganglion Cysts Antioxidants Basal Ganglia Diseases Central Nervous System Diseases Dopamine Agonists Brain Diseases |
Neurodegenerative Diseases Pramipexol Dopamine Parkinson Disease Movement Disorders Dihydroxyphenylalanine Dopamine Agents Parkinsonian Disorders |
Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Dopamine Agonists Brain Diseases |
Neurodegenerative Diseases Protective Agents Pramipexol Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |