NCT01425359

Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 949 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants who meet the eligibility criteria at screening will enter a 4-to 6-week Qualifying Period. The allowed concomitant antianginal medication(s) must be maintained at a stable dose throughout the study. Participants will document the number of angina episodes, number of sublingual nitroglycerin doses taken, and a dyspnea score (on a scale from 1 to 5) on a daily basis in a diary. Participants eligible to stay in the study after the Qualifying Period will enter the 8-week double-blind dosing phase. Participants will have study visits at the end of Weeks 2 and 8. Participants will continue to document the number of angina episodes and number of sublingual nitroglycerin doses taken as well as a dyspnea score on a daily basis by the end of each day in their diary. In addition, participants will be called during Week 2 and at the end of Week 5 to encourage compliance. A safety follow-up phone call will be made 14 days after the last study visit or early discontinuation.

Conditions

• Angina Pectoris
• Coronary Artery Disease
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ranolazine
DRUG	Ranolazine placebo

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-08-30
• Last updated: 2014-11-04
• Results posted: 2014-11-04

Locations

135 sites across 14 countries: United States, Belarus, Bulgaria, Canada, Czechia, Georgia, Germany, Israel, Poland, Russia, Serbia, Slovakia, Slovenia, Ukraine