CLINICAL TRIAL
CLINICAL TRIAL, PHASE III
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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Comparison of the safety and efficacy of delapril with captopril in outpatients with congestive heart failure.

In this study delapril and captopril were compared in outpatients with congestive heart failure (CHF), New York Heart Association (NYHA) classes III and IV, in a double-blind study of efficacy and safety. Efficacy was evaluated by monitoring changes in the NYHA classification, exercise work, hemodynamic parameters, Kostuk's classification, and clinical signs and symptoms. Safety was monitored by a variety of laboratory tests, including renal and hepatic function, urinalysis, routine hematology testing, and the reporting of adverse events. Analysis of the data obtained revealed that delapril and captopril exhibit equal efficacy over the dosage ranges studied. There was a greater improvement of NYHA classification in terms of CHF signs and symptoms and ergometric workload in the delapril group; however, this did not reach statistical significance. The safety of the 2 drugs was also comparable, with no significant differences in any of the parameters measured at the start and end of the study. There was no statistically significant difference in the reporting of adverse events between the 2 drugs, although the sample size studied was small. There were no significant differences between the 2 drugs in terms of their effects on arterial blood pressure and no difference between prestudy and post-treatment arterial blood pressure measurements.

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