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

NCT01425359 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 949

Last updated 2014-11-04

Study results available
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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.

Conditions

Interventions

DRUG

Ranolazine

DRUG

Ranolazine placebo

Sponsors & Collaborators

Principal Investigators

  • Patrick Yue, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Belarus
  • Bulgaria
  • Canada
  • Czechia
  • Georgia
  • Germany
  • Israel
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425359 on ClinicalTrials.gov