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TerminatedNCT00738972Updated Aug 26, 2013Results posted

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

A Phase 3 interventional study of valsartan and pravastatin in Hypertension, sponsored by Fundación Lindavista del Corazón AC. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-26.

Sponsored by Fundación Lindavista del Corazón AC · Phase 3, Interventional, and Treatment

Why this study was terminated
Study terminated early due to sample size, not possible to perform further statistical analysis.
Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Evaluate pleiotropic effects of simvastatin in hypertensive patients.

02

Conditions studied

03

In context

Hypertrophy, Left Ventricular

120 studies on the registry are indexed under Hypertrophy, Left Ventricular; 23 are open to participants now.

This study's enrollment of 12 is below the median of 120 across 69 interventional studies indexed under Hypertrophy, Left Ventricular.

Browse Hypertrophy, Left Ventricular studies →

Lead sponsor

This is the only study on the registry with Fundación Lindavista del Corazón AC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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 · Drug: pravastatin

  • 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: valsartan · Drug: simvastatin

  • 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: valsartan · Drug: ezetimibe (+) simvastatin

  • Active comparator
    Valsartan 80 mg

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

    Drug: valsartan

Interventions

  • Drugvalsartan

    80 mg valsartan. Duration: 12 months. Tablets

    Also known as: Diovan

  • Drugpravastatin

    40 mg pravastatin. Duration: 12 months. Tablets

    Also known as: Pravacol

  • Drugsimvastatin

    40 mg simvastatin. Duration: 12 months. Tablets

    Also known as: Zocor, MK0733

  • Drugezetimibe (+) simvastatin

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

    Also known as: vytorin, MK0653A

06

What researchers measure

Primary outcomes

  1. Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients

    Left ventricular hypertrophy reduction was to be measured by echocardiography.

    Time frame: 6 Month(s)

07

Results

Posted Aug 13, 2013
Limitations and caveats
This study was terminated early and due to sample size it was not possible to perform further statistical analyses.

Participant flow

Participant flow — Overall Study
MilestoneValsartan 80 mg + Paravastin 40 mgValsartan 80 mg + Simvastatin 40 mgValsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mgValsartan 80 mg
Started3333
Completed3332
Not completed0001

Outcome measures

PrimaryLeft Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients

Left ventricular hypertrophy reduction was to be measured by echocardiography.

Time frame:
6 Month(s)

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Valsartan 80 mg + Paravastin 40 mg—0/3 (0%)0/3 (0%)
Valsartan 80 mg + Simvastatin 40 mg—0/3 (0%)0/3 (0%)
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg—0/3 (0%)0/3 (0%)
Valsartan 80 mg—0/2 (0%)0/2 (0%)

Baseline characteristics

Age, Customized
Age, Customized(participants)Valsartan 80 mg + Paravastin 40 mgValsartan 80 mg + Simvastatin 40 mgValsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mgValsartan 80 mgTotal
>18 years333211
Sex: Female, Male
Sex: Female, Male(Participants)Valsartan 80 mg + Paravastin 40 mgValsartan 80 mg + Simvastatin 40 mgValsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mgValsartan 80 mgTotal
Female22228
Male11103
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00738972
Lead sponsor
Fundación Lindavista del Corazón AC
Responsible party
Sponsor
First posted
Aug 21, 2008
Start date
Jan 2008
Primary completion
Aug 2010
Completion
Aug 2010
Results posted
Aug 13, 2013
Last update
Aug 26, 2013

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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