ANGIOTENSIN-II ANTAGONIST GCP-48933 (VALS ARTAN) - RESULTS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY

The objective of the trial was to obtain some results on the clinical safety and subjective tolerability of the angiotensin-II-antagonist CG P 48933 (Angiotensin-II-AT1-receptor-antagonist). Ninety patients were randomized and following a single blind placebo phase were actively t reated with a weekly increasing (20, 40, 80 and 160 mg) dosage of CGP 48933 or placebo. Parameters investigated were the extent of blood pre ssure reduction, adverse experience, and standard laboratory parameter s. 29 out of 72 patients had at least one adverse experience. In the p lacebo group the relationship was 4 out of 18 patients with an adverse experience. In the CGP 48933 group 31% of the patients had an adverse experience related to the test medication and 11% in the placebo grou p. The adverse experiences while being treated with CGP 48933 were pri marily headaches, dizziness, weakness, and hypotension. Headaches were the main adverse experience in the placebo group. Patients did not ex perience dry coughs or angio-neurotic oedema while being treated with CGP 48933. No trends indicating changes in the examined laboratory par ameters were observed in patients treated with CGP 48933. The mean RR reduction (sitting) observed after treatment with CGP 48933 at the end of the test period was 20.0/15.1 mmHg, and 3.7/5.5 mmHg in the placeb o group, the difference in the reduction was 16.3/9.6 mmHg (p <0.001). The study showed that CGP 48933 is subjectively well tolerable, has n o influence on the lab parameters and significantly reduces blood pres sure over the observation period (four weeks).