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)
Abstract
The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo
Conditions: Healthy.
Primary outcome: Mean of the individually heart rate corrected QT interval (QTcI) values.
Enrollment: 60 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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