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A Phase I Single Centre, Randomized, Double Blind (Except For Moxifloxacin), Placebo And Active Controlled, Four Way Cross Over Study Investigating The Effect Of Single Therapeutic And Supra Therapeutic Doses Of Fedovapagon On The QT/QTC Interval In Healthy Volunteers Using Oral Moxifloxacin To Confirm Assay Sensitivity

ClinicalTrials.gov · COMPLETED, 2015

43 participants

Abstract

The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects.

Conditions: Healthy.

Primary outcome: Time-matched change from baseline in QTc, placebo-adjusted and corrected for heart rate.

Enrollment: 43 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: 43 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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