Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219141

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/losartan Drug: Aliskiren Drug: Losartan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Losartan Losartan potassium Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in left ventricular mass index using magnetic resonance imaging (MRI) for aliskiren 300 mg/losartan 100mg combination compared to losartan 100 mg [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in LVMI as measured by MRI for aliskiren 300 mg compared to losartan 100 mg [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Change from baseline in LVH parameters as measured by MRI for aliskiren 300 mg/losartan 100 mg combination compared to each monotherapy [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Change in LVH parameters as measured by MRI for aliskiren 300 mg and losartan 100 mg monotherapies [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment:	465
Study Start Date:	August 2005
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren 300 mg/losartan 100 mg	Drug: Aliskiren/losartan aliskiren 300 mg/losartan 100mg
2: Experimental aliskiren 300 mg	Drug: Aliskiren Aliskiren 300 mg
3: Active Comparator losartan 100 mg	Drug: Losartan Losartan 100 mg

Eligibility

Ages Eligible for Study:	18 Years and older
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).

Contacts and Locations

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
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs ( Novartis Pharmaceuticals )
Study ID Numbers:	CSPP100A2316
Study First Received:	September 12, 2005
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00219141 History of Changes
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Losartan
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Overweight
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Angiotensin II Type 1 Receptor Blockers
Body Weight
Signs and Symptoms
Hypertrophy
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiomegaly
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010