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NCT02262546
A Double-blind, Randomised, Placebo Controlled Study With Two Sequential Two-way Cross-over Parts to Demonstrate That the Influence of Pramipexole up to 4.5 mg Daily on the QT Interval of the ECG in Healthy Male and Female Volunteers is Comparable With Placebo, With a Positive Control (Two-way Cross-over Moxifloxacin Versus Placebo)
Phase 1 trial testing Pramipexole extended-release (ER) tablets in Healthy in 60 participants. Completed.
1 October 2007
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 May 2007 |
| Primary completion | 1 October 2007 |
Drugs / interventions tested
- Pramipexole extended-release (ER) tablets
- Pramipexole immediate-release (IR) tablets
- Moxifloxacin (moxifloxacin) — full drug profile →
- Pramipexole Placebo
- Moxifloxacin Placebo — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
Adults 21 to 50, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean of the individually heart rate corrected QT interval (QTcI) values
Time frame: 1 to 4 hours after dosing on day 21
Sponsor's own description
The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo
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:
- PubMed search for NCT02262546
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Boehringer Ingelheim trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02262546 (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: 9 October 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/NCT02262546.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing