CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 860 enrolled
Drug / intervention
Amlodipine +2 moredrug
Likely dose
Amlodipine 5 mgfrom 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/NCT00787605
NCT00787605Phase 4Completed
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An 8-week Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to Amlodipine (10 mg) in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

Novartis·interventional·Posted Nov 7, 2008·Updated Oct 27, 2016

In Brief

A Phase 4 clinical trial evaluating Amlodipine, Hydrochlorothiazide (HCTZ), and 1 other intervention for Hypertension and Diabetes Mellitus. Completed, enrolled 860 participants across 1 site.

Detailed Summary

The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and \< 200 mm Hg).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 7, 2008
Enrollment StartNov 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.7 years ago

Interventions

Amlodipinedrug

Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks

Hydrochlorothiazide (HCTZ)drug

Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks

Aliskirendrug

Aliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks