CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 688 enrolled
Drug / intervention
Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) +1 moredrug
Likely dose
Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00705575
NCT00705575Phase 3Completed
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A 12 Week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg Compared to Aliskiren 300 mg in Patients With Stage II Hypertension

Novartis·interventional·Posted Jun 26, 2008·Updated May 30, 2011

In Brief

A Phase 3 clinical trial evaluating Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) and Aliskiren (300 mg) for Hypertension. Completed, enrolled 688 participants across 8 sites in 8 countries.

Detailed Summary

This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesArgentina, Ecuador, Germany, Guatemala, Italy, Switzerland, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 26, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.0 years ago

Interventions

Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)drug

During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.

Aliskiren (300 mg)drug

During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.