Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00738972

Purpose

Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Condition	Intervention	Phase
Hypertension	Drug: valsartan Drug: pravastatin Drug: simvastatin Drug: ezetimibe (+) simvastatin	Phase IV

MedlinePlus related topics: High Blood Pressure Statins

Drug Information available for: Valsartan Pravastatin Pravastatin sodium Simvastatin Ezetimibe Vytorin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.

Further study details as provided by Merck:

Primary Outcome Measures:

Left ventricular mass reduction. [ Time Frame: 6 Month(s) ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	July 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Arm 1; Comparators	Drug: valsartan 80 mg valsartan. Duration: 12 months. Tablets Drug: pravastatin 40mg pravastatin. Duration: 12 months. Tablets
2: Active Comparator Arm 2: Comparators	Drug: valsartan 80 mg valsartan. Duration: 12 months. Tablets Drug: simvastatin 20 mg simvastatin. Duration: 12 months. Tablets
3: Experimental Arm 3: Drug	Drug: valsartan 80 mg valsartan. Duration: 12 months. Tablets Drug: ezetimibe (+) simvastatin ezetimibe (+) simvastatin 10/20mg. Duration: 12 months. Tablets
4: Active Comparator Arm 4: Comparators	Drug: valsartan 80 mg valsartan. Duration: 12 months. Tablets

Eligibility

Criteria

Inclusion Criteria:

Females Or Males Over 18 Years Old
Patients With Systemic Arterial Hypertension Grade I And Ii According With The European Society Of Cardiology
Left Ventricular hypertrophy Demonstrated By Echocardiography
Mild To Moderated hypercholesterolemia
Willing To Participate And Sign The Informed Consent Form (ICF)

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738972

Locations

Mexico, D.F.
Merck Sharp & Dohme De Mexico, S.A. De C.V.	Recruiting
Mexico, D.F., Mexico, 1090
Contact: Juan Diaz 52-55-5481-9825

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_020, MK0653A-168
Study First Received:	August 19, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00738972
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Pravastatin
Hypertrophy, Left Ventricular
Hypertrophy
Heart Diseases
Simvastatin

Vascular Diseases
Ezetimibe
Cardiomegaly
Valsartan
Hypertension

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases

Cardiovascular Agents
Anticholesteremic Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009