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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00434304 |
Purpose
This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: SK&F106064 (Ropinirole) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - <Clinical Pharmacology / Exploratory Study> |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who have been treated with the following drugs at Week -4, and whose treatment regimen of the drug has been changed from Week-4 to Week0.
<Rationale for the exclusion criteria>
Contacts and Locations| Japan | |
| GSK Investigational Site | |
| Aichi, Japan, 455-0018 | |
| GSK Investigational Site | |
| Chiba, Japan, 279-0021 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 070-0901 | |
| GSK Investigational Site | |
| Kyoto, Japan, 600-8811 | |
| GSK Investigational Site | |
| Aichi, Japan, 460-0008 | |
| GSK Investigational Site | |
| Kanagawa, Japan, 251-0038 | |
| GSK Investigational Site | |
| Tokyo, Japan, 136-0075 | |
| GSK Investigational Site | |
| Osaka, Japan, 570-8507 | |
| GSK Investigational Site | |
| Tokyo, Japan, 113-0033 | |
| GSK Investigational Site | |
| Iwate, Japan, 020-0878 | |
| GSK Investigational Site | |
| Ehime, Japan, 791-0204 | |
| GSK Investigational Site | |
| Saitama, Japan, 343-0032 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | ROP106064 |
| Study First Received: | February 9, 2007 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00434304 History of Changes |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency; Japan: Ministry of Health, Labor and Welfare |
|
PD Parkinson's Disease |
|
Ropinirole Neurotransmitter Agents Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Dopamine Agonists Dopamine Parkinson Disease Movement Disorders Dopamine Agents Parkinsonian Disorders |
|
Neurotransmitter Agents Ropinirole Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Antiparkinson Agents Dopamine Agonists |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |