CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 949 enrolled
Drug / intervention
Ranolazine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01425359
NCT01425359Phase 4Completed

A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Ranolazine in Subjects With Chronic Stable Angina and Coronary Artery Disease With a History of Type 2 Diabetes Mellitus

Gilead Sciences·interventional·Posted Aug 30, 2011·Updated Nov 4, 2014

In Brief

A Phase 4 clinical trial evaluating Ranolazine and Ranolazine placebo for Angina Pectoris and 2 related conditions. Completed, enrolled 949 participants across 135 sites in 14 countries.

Detailed Summary

This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to record their daily angina episodes in a diary at the end of each study day. Ranolazine is approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelarus, Bulgaria, Canada, Czechia, Georgia, Germany, Israel, Poland, Russia, Serbia, Slovakia, Slovenia, Ukraine, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2011
Enrollment StartSep 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.8 years ago

Interventions

Ranolazinedrug

Ranolazine placebodrug