Trial Information

Summary: A Study of Dilatrend (Carvedilol) in the Treatment of Patients With Chronic Stable Angina Pectoris

Status: Completed

Protocol Number: ML18030

Sponsor: Shanghai Roche Pharmaceuticals Ltd.

Company Division: Pharmaceutical

Official Scientific Title: An open, randomized, controlled, multicenter study to assess the change in time to onset of 1-mm-ST-segment depression produced by carvedilol (Dilatrend) versus metoprolol in patients with chronic stable angina pectoris

Brief Summary: This study will compare the efficacy and safety of carvedilol versus a comparator drug, in patients with chronic stable angina pectoris. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 144.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Angina Pectoris

Intervention Type: Drug

Intervention Name: carvedilol[Dilatrend]

Primary Outcome: 1. Efficacy: change in time to onset of 1-mm-ST-segment depression

Key Secondary Outcomes: 1. Exercise parameters; Frequency of angina pectoris episodes, and dose of nitroglycerin used. Safety: incidence of adverse events

Inclusion Criteria:

  • adult patients 18-70 years of age;
  • chronic angina pectoris;
  • stable for at least the preceding 2 months;
  • exertional angina pectoris, with symptoms improving after short-acting nitrates or rest (female patients should have results of angiocardiography within 3 months);
  • positive treadmill exercise test.

Exclusion Criteria:

  • myocardial infarction or cardiac surgery within 3 months of enrollment;
  • stroke or transient ischemic attack within 6 months of enrollment;
  • resting heart rate <45 beats per minute, or pacemaker;
  • uncontrolled hypertension;
  • insulin-dependent diabetes mellitus.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 70 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 03/10/2006

Date Last Updated: 10/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Beijing, China, 100034
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: November 17, 2008 at 2:38:33 PM


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