At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,143 enrolled
Drug / intervention
Aliskiren +3 moredrug
Likely dose
Aliskiren 150 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.
An 8 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Antihypertensive Efficacy and Safety of Aliskiren Administered in Combination With Valsartan Versus Valsartan Alone in Patients With Stage 2 Systolic Hypertension and Type 2 Diabetes Mellitus
In Brief
A Phase 4 clinical trial evaluating Aliskiren, Valsartan, and 2 other interventions for Hypertension. Completed, enrolled 1,143 participants across 4 sites.
Detailed Summary
The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedJun 2009
Primary CompletionOct 2011
TodayJul 2026
First PostedJun 25, 2009
Enrollment StartMay 1, 2009
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.0 years ago
Interventions
Aliskirendrug
Aliskiren 150 mg tablet
Valsartandrug
Valsartan 160 mg capsules
Placebo for Aliskirendrug
Placebo for Aliskiren 150 mg tablets
Placebo for Valsartandrug
Placebo for Valsartan 160 mg capsules