Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168) - Full Text View

Sponsor:	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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 Vytorin

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 ]

Enrollment:	11
Study Start Date:	January 2008
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Valsartan 80 mg + Paravastin 40 mg Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)	Drug: valsartan 80 mg valsartan. Duration: 12 months. Tablets Other Names: valsartan Diovan
Active Comparator: Valsartan 80 mg + Simvastatin 40 mg Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)	Drug: pravastatin 40 mg pravastatin. Duration: 12 months. Tablets Other Names: pravastatin Pravacol
Experimental: Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)	Drug: simvastatin 20 mg simvastatin. Duration: 12 months. Tablets Other Names: simvastatin Zocor MK0733
Active Comparator: Valsartan 80 mg Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)	Drug: ezetimibe (+) simvastatin ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets Other Names: vytorin MK0653A

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:	Vice President of Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00738972 History of Changes
Obsolete Identifiers:	NCT00621127
Other Study ID Numbers:	MK-0653A-168, 2008_020
Study First Received:	August 19, 2008
Last Updated:	August 16, 2011
Health Authority:	Mexico: Ministry of Health

Additional relevant MeSH terms:

Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Simvastatin
Pravastatin
Ezetimibe
Valsartan
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012