Clinical Trial Result Information

Protocol number
ML18030

Title of Study
An open label, randomized, active controlled, multicentre study to assess efficacy and safety of carvedilol versus metoprolol in patients with chronic stable angina pectoris.

Sponsor
Shanghai Roche Pharmaceutical Ltd

Company division
Pharmaceutical

Product name
Dilatrend

Generic name
carvedilol

Therapeutic area
Angina Pectoris

Clinical study summary
This trial was prematurely terminated, due to slow recruitment. Clinical trial results, other than safety statements, have not been posted, due to insufficient data.

Study center(s)
10 centers in China.

Phase of development
III

Objectives
1) To compare the efficacy of Dilatrend (carvedilol) twice daily and metoprolol twice daily in patients with chronic stable angina pectoris; 2) To study the safety of Dilatrend.

Methodology
The study duration was 16 weeks (2 weeks screening, 4 weeks low dose treatment, 8 weeks final dose treatment and 2 weeks down titration). After randomization, patients were treated with low dose Dilatrend or metoprolol for 4 weeks. After 4 weeks low dose treatment, patients were titrated to the higher dose. After a further 8 weeks of active treatment study medications were tapered off over the subsequent 2 weeks.

Number of patients (planned/analyzed)
144 planned; 44 enrolled.

Diagnosis and main criteria for inclusion
Patients ≥18 and ≤70 years of age with chronic stable angina pectoris, and with a positive treadmill exercise test.

Test product, dose and mode of administration or test procedure
Dilatrend (carvedilol tablet) 25 mg bid for 4 weeks, a maximum of 50 mg bid for 8 weeks, 2 weeks down-titration.

Duration of treatment
14 weeks.

Reference therapy, dose and mode of administration or reference procedure
Metoprolol tablet 50 mg bid for 4 weeks, a maximum of 100 mg bid for 8 weeks, 2 weeks down-titration.

Criteria for evaluation (efficacy, safety)
Efficacy: Change of time to onset of 1-mm-ST-segment depression (in referred precordial leads).
Safety: Incidence of adverse events, change in vital signs, laboratory values.

Statistical methods
Because of the premature termination of the study, there was no evaluation of the primary efficacy parameter. Safety data were evaluated descriptively.

Summary (efficacy, safety, other results)
One patient in the metoprolol group was hospitalized due to acute coronary syndrome; this SAE was not considered related to treatment. No SAE occurred in the Dilatrend group.

Conclusions
No conclusions can be drawn from this study, due to its early termination.

Date of report
4/1/2006

Click here for the protocol registry listing of this trial.