drugset / Trial / NCT00942994

Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension

NCT00942994 ↗

Phase 4 Completed 412 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.

Timeline

Start
2009-06
Primary completion
2010-03
Completion
—

Outcome

Met primary endpoint

paper to 130.7 mm Hg at week 8 with aliskiren/amlodipine/HCTZ and from 167.4 mm Hg to 137.9 mm Hg with aliskiren/amlodipine (P < .0001 between groups). PMID 21414565 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aliskiren Small molecule 300 mg —
Subject Amlodipine Other / unclassified 10 mg —
Subject Hydrochlorothiazide Unknown 25 mg —

Indications