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

This study has been terminated.
(Study terminated early due to sample size, not possible to perform further statistical analysis.)
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00738972
First received: August 19, 2008
Last updated: August 16, 2011
Last verified: August 2011
History of Changes
  Purpose

Evaluate pleiotropic effects of simvastatin in hypertensive patients.


Condition Intervention Phase
Hypertension
 Drug: valsartan
Drug: pravastatin
Drug: simvastatin
Drug: ezetimibe (+) simvastatin
 Phase 3

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:

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 May 19, 2013