Trials / Withdrawn

WithdrawnNCT01334203

A Study on the Effects of Ranolazine on Exercise Duration in Subjects With Chronic Stable Angina and Coronary Artery Disease (CAD) With Type 2 Diabetes Mellitus (T2DM)

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Status: Withdrawn
Phase: Phase 4
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Gilead Sciences · Industry
Sex: All
Age: 18 Years – 79 Years
Healthy volunteers: Not accepted

Summary

Detailed description

This study will evaluate the efficacy of ranolazine compared to placebo on duration of exercise assessed by exercise tolerance testing (ETT) at anticipated peak ranolazine plasma concentration after 12 weeks of treatment in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM). This is a randomized, double-blind, placebo-controlled, parallel group study in subjects with chronic stable angina and CAD receiving a stable dose of a single concomitant antianginal medication who also have a history of T2DM; allowed antianginals will be a beta-blocker (atenolol or metoprolol) or a calcium-channel blocker.

Conditions

Interventions

Type	Name	Description
DRUG	Ranolazine	Subjects will be randomized to either ranolazine 500 mg twice daily up-titrated on Day 4 to 1000 mg administered orally twice a day or matching placebo for the 12 week treatment period. Subjects receiving diltiazem or verapamil as their concomitant antianginal medication will receive ranolazine 500 mg or placebo administered orally twice a day.

Timeline

Start date: 2011-05-01
Primary completion: 2012-10-01
Completion: 2012-12-01
First posted: 2011-04-13
Last updated: 2012-07-31

Source: ClinicalTrials.gov record NCT01334203. Inclusion in this directory is not an endorsement.