Clinical Trial Result Information

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.

Fast Facts:

Protocol number:	ML18030
Sponsor:	Shanghai Roche Pharmaceutical Ltd
Company division:	Pharmaceutical
Product name:	Dilatrend
Generic name:	carvedilol
Phase of development:	III
Therapeutic area, approved indication:	Angina Pectoris
Date of report:	4/1/2006

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.

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.

Click here for the protocol registry listing of this trial.