drugset / Trial / NCT00564187

Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice

NCT00564187

Phase 4 Completed 115 enrolled Sanofi Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary: * To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks) Secondary: * To evaluate the percentage of patients with DBP \< 90 mmHg at 6 and 12 weeks * To evaluate the percentage of patients with SBP \< 140 mmHg at 6 and 12 weeks * To evaluate rate of adverse events during the study

Timeline

Start
2003-02
Primary completion
Completion
2004-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Irbesartan Small molecule 150 mg
Comparator Irbesartan Small molecule 300 mg

Indications