NCT00738972

Brief Summary

Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Jan 2008

Typical duration for phase_3 hypertension

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3 years until next milestone

Results Posted

Study results publicly available

August 13, 2013

Completed
Last Updated

August 26, 2013

Status Verified

August 1, 2013

Enrollment Period

2.6 years

First QC Date

August 19, 2008

Results QC Date

July 20, 2013

Last Update Submit

August 17, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients

    Left ventricular hypertrophy reduction was to be measured by echocardiography.

    6 Month(s)

Study Arms (4)

Valsartan 80 mg + Paravastin 40 mg

ACTIVE COMPARATOR

Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)

Drug: valsartanDrug: pravastatin

Valsartan 80 mg + Simvastatin 40 mg

ACTIVE COMPARATOR

Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)

Drug: valsartanDrug: simvastatin

Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg

EXPERIMENTAL

Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)

Drug: valsartanDrug: ezetimibe (+) simvastatin

Valsartan 80 mg

ACTIVE COMPARATOR

Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)

Drug: valsartan

Interventions

valsartanDRUG

80 mg valsartan. Duration: 12 months. Tablets

Also known as: Diovan
Valsartan 80 mgValsartan 80 mg + Paravastin 40 mgValsartan 80 mg + Simvastatin 40 mgValsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg
pravastatinDRUG

40 mg pravastatin. Duration: 12 months. Tablets

Also known as: Pravacol
Valsartan 80 mg + Paravastin 40 mg
simvastatinDRUG

40 mg simvastatin. Duration: 12 months. Tablets

Also known as: Zocor, MK0733
Valsartan 80 mg + Simvastatin 40 mg
ezetimibe (+) simvastatinDRUG

ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets

Also known as: vytorin, MK0653A
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Type 1 Or 2 Diabetes Mellitus
  • Familiar hypercholesterolemia
  • Low Density Lipoprotein-Cholesterol (LDL-C) \> 190 mg/dl
  • History Of Myocardial Infarction Or Stable Chronic Angina
  • Triglycerides \>250 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanPravastatinSimvastatinEzetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsLovastatinEzetimibeAzetidinesAzetinesDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

This study was terminated early and due to sample size it was not possible to perform further statistical analyses.

Results Point of Contact

Title
Vice President, Late Stage Development Group Leader
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 26, 2013

Results First Posted

August 13, 2013

Record last verified: 2013-08