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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00219141
First received: September 12, 2005
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Hypertension
Left Ventricular Hypertrophy
Overweight
Drug: Aliskiren 150/300 mg
Drug: Losartan 50/100 mg
Drug: Aliskiren placebo
Drug: Losartan 50/100 mg placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
    Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.


Secondary Outcome Measures:
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36) [ Time Frame: Baseline to end of study (Week 36) ] [ Designated as safety issue: No ]
  • Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36) [ Time Frame: Baseline the end of study (Week 36) ] [ Designated as safety issue: No ]
    Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, blood pressure was measured at study specified intervals.


Enrollment: 460
Study Start Date: October 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren 300 mg
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.
Drug: Aliskiren 150/300 mg
Aliskiren 150 mg tablets
Drug: Aliskiren placebo
Aliskiren 150 mg placebo tablet
Drug: Losartan 50/100 mg placebo
Losartan 50/100 mg placebo capsules
Active Comparator: Losartan 100 mg
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.
Drug: Losartan 50/100 mg
Losartan 50 or 100 mg capsules
Drug: Aliskiren placebo
Aliskiren 150 mg placebo tablet
Experimental: Aliskiren/losartan 300/100 mg
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.
Drug: Aliskiren 150/300 mg
Aliskiren 150 mg tablets
Drug: Losartan 50/100 mg
Losartan 50 or 100 mg capsules
Drug: Aliskiren placebo
Aliskiren 150 mg placebo tablet

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00219141

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Argentina
sites in Argentina
Argentina, Argentina
Colombia
sites in Colombia
Colombia, Colombia
Finland
sites in Finland
Finland, Finland
Germany
sites in Germany
Germany, Germany
Italy
sites in Italy
Italy, Italy
Russian Federation
sites in Russia
Russia, Russian Federation
Spain
sites in Spain
Spain, Spain
Sweden
sites in Sweden
Sweden, Sweden
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals, External Affairs
ClinicalTrials.gov Identifier: NCT00219141     History of Changes
Other Study ID Numbers: CSPP100A2316
Study First Received: September 12, 2005
Results First Received: January 11, 2011
Last Updated: May 20, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Hypertension
Overweight
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014