Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
China
