NCT00560508 is a Phase 2/Phase 3 clinical trial of Pramipexole Immediate Release in Parkinson Disease, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT00560508?

NCT00560508 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT00560508?

Interventions in NCT00560508: Pramipexole Immediate Release, Pramipexole Extended Release.

What condition does NCT00560508 study?

NCT00560508 studies Parkinson Disease.

Is NCT00560508 still recruiting?

NCT00560508 is currently completed. Last updated 29 July 2014.

Are results published for NCT00560508?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-07-29 · How we verify

NCT00560508

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2/Phase 3 Results posted Last updated 29 July 2014

What this trial tests

Phase 2/Phase 3 trial testing Pramipexole Immediate Release in Parkinson Disease in 112 participants. Completed.

Timeline

1 November 2007

Primary endpoint
1 November 2009

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	112
Start date	1 November 2007
Primary completion	1 November 2009
Sites	19 locations across Japan

Drugs / interventions tested

Pramipexole Immediate Release — full drug profile →
Pramipexole Extended Release

Conditions studied

Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

1 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants Who Experienced Adverse Events
Time frame: 12 weeks
An adverse event is defined as any untoward medical occurrence

Sponsor's own description

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 levodopa (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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

NCT07399496 — Accelerated TMS for Apathy in PD · NA · recruiting
NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
NCT07442370 — The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients · NA · recruiting
NCT06848205 — Percept Transitions in FOG and PD · NA · recruiting
NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00560508 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 29 July 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00560508.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing