At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 460 enrolled
Drug / intervention
Aliskiren 150/300 mg +3 moredrug
Likely dose
Aliskiren 150–300 mg once daily in combination with losartan 50–100 mg once dailyAI-extracted
Key inclusion· 3
- ✓Essential hypertension diagnosis
- ✓BMI > 25 kg/m²
- ✓Left ventricular hypertrophy confirmed by echocardiogram with LVWT ≥ 1.3 cm
Key exclusion· 3
- ✕ACE inhibitor or ARB use within 3 months prior to study entry (unable or unwilling to undergo 3-month washout)
- ✕Current ACE and ARB combination therapy
- ✕Secondary hypertension of any cause (e.g., uncorrected renal artery stenosis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 36-week, Randomized, Double-blind, Multi-center, Parallel Group Study Comparing the Efficacy and Safety of Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension
In Brief
A Phase 3 clinical trial evaluating Aliskiren 150/300 mg, Losartan 50/100 mg, and 2 other interventions for Hypertension and 2 related conditions. Completed, enrolled 460 participants across 9 sites in 9 countries.
Detailed Summary
To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Left Ventricular Hypertrophy, Overweight
CountriesArgentina, Colombia, Finland, Germany, Italy, Russia, Spain, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2005
Enrollment StartOct 2005
Primary CompletionNov 2007
TodayJul 2026
First PostedSep 22, 2005
Enrollment StartOct 1, 2005
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.8 years ago
Interventions
Aliskiren 150/300 mgdrug
Aliskiren 150 mg tablets
Losartan 50/100 mgdrug
Losartan 50 or 100 mg capsules
Aliskiren placebodrug
Aliskiren 150 mg placebo tablet
Losartan 50/100 mg placebodrug
Losartan 50/100 mg placebo capsules