Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension (ALLAY)

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension; Overweight; Left Ventricular Hypertrophy

Treatments: Drug: Losartan 50/100 mg; Drug: Aliskiren 150/300 mg; Drug: Losartan 50/100 mg placebo; Drug: Aliskiren placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219141

CSPP100A2316

Details and patient eligibility

About

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.

Enrollment: 460 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with essential hypertension
• Patients with a BMI > 25 kg/m2
• Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO

Exclusion criteria

• Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1) who are unable or unwilling to undergo the 3 month washout period.
• Patients treated with an ACE and ARB combination at study entry.
• Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).

Other protocol related inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 3 patient groups

Aliskiren 300 mg

Experimental group

Description:

Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan placebo. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan placebo. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.

Treatment:

Drug: Aliskiren placebo

Drug: Aliskiren 150/300 mg

Drug: Losartan 50/100 mg placebo

Losartan 100 mg

Active Comparator group

Description:

Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.

Treatment:

Drug: Aliskiren placebo

Drug: Losartan 50/100 mg

Aliskiren/losartan 300/100 mg

Experimental group

Description:

Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed.

Treatment:

Drug: Aliskiren placebo

Drug: Aliskiren 150/300 mg

Drug: Losartan 50/100 mg