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

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.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Statins

Drug Information available for: Simvastatin Pravastatin Pravastatin sodium Valsartan Ezetimibe

U.S. FDA Resources

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:	June 2010 (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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Type 1 Or 2 Diabetes Mellitus
Familiar hypercholesterolemia
C-LDL > 190 Mg/Dl
History Of Myocardial Infarction Or Stable Chronic Angina
Triglycerides >250 Mg/Dl

Contacts and Locations

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

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:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00738972 History of Changes
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Antimetabolites
Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Heart Diseases
Simvastatin
Antilipemic Agents
Vascular Diseases
Ezetimibe
Cardiovascular Agents

Anticholesteremic Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pravastatin
Hypertrophy
Cardiomegaly
Valsartan
Hypertension

Additional relevant MeSH terms:

Antimetabolites
Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Ezetimibe
Cardiovascular Agents

Anticholesteremic Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Pravastatin
Hypertrophy
Therapeutic Uses
Cardiovascular Diseases
Cardiomegaly
Valsartan
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009