drugset / Trial / NCT00950066

Irbesartan and Amlodipine Combination in Controlling Blood Pressure

NCT00950066

Phase 2 Completed 270 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo. The secondary objectives are: * to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo. * to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.

Timeline

Start
2009-07
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 5 mg Oral
Comparator Irbesartan Small molecule 150 mg Oral
Comparator Irbesartan Small molecule 300 mg Oral