HypertensionPhase 3NCT00738972
Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)
A Phase 3 study testing valsartan, pravastatin and simvastatin in people with Hypertension, run by Fundación Lindavista del Corazón AC.
Trial summary
Evaluate pleiotropic effects of simvastatin in hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan, pravastatin and simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Aug 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.
Evaluate pleiotropic effects of simvastatin in hypertensive patients.
- Conditions
- Hypertension
- Being tested
- valsartan, pravastatin, simvastatin, ezetimibe (+) simvastatin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
Also called Diovan
80 mg valsartan. Duration: 12 months. Tablets
pravastatinDrug
Also called Pravacol
40 mg pravastatin. Duration: 12 months. Tablets
simvastatinDrug
Also called Zocor, MK0733
40 mg simvastatin. Duration: 12 months. Tablets
ezetimibe (+) simvastatinDrug
Also called vytorin, MK0653A
ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: valsartan; Drug: 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) Receives: Drug: valsartan; Drug: 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) Receives: Drug: valsartan; Drug: ezetimibe (+) simvastatin |
| Valsartan 80 mg | Active comparator | Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) Receives: Drug: valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients
Left ventricular hypertrophy reduction was to be measured by echocardiography.
Measured: 6 Month(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Study terminated early due to sample size, not possible to perform further statistical analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Lindavista del Corazón AC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738972
- Sponsor's protocol ID
- MK-0653A-168
- Other IDs
- 2008_020
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2008
- Last updated
- 26 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.
- ClinicalTrials.gov ID
- NCT00738972
- Acronym / sponsor ID
- MK-0653A-168
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to sample size, not possible to perform further statistical analysis.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundación Lindavista del Corazón ACUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Posted 13 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate pleiotropic effects of simvastatin in hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Valsartan 80 mg + Paravastin 40 mg | Active comparator | Drug: valsartan, Drug: pravastatinParticipants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A) |
| Valsartan 80 mg + Simvastatin 40 mg | Active comparator | Drug: valsartan, Drug: simvastatinParticipants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B) |
| Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | Experimental | Drug: valsartan, Drug: ezetimibe (+) simvastatinParticipants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C) |
| Valsartan 80 mg | Active comparator | Drug: valsartanParticipants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valsartanAlso: Diovan80 mg valsartan. Duration: 12 months. Tablets | Drug | Valsartan 80 mg, Valsartan 80 mg + Paravastin 40 mg, Valsartan 80 mg + Simvastatin 40 mg, Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg |
| pravastatinAlso: Pravacol40 mg pravastatin. Duration: 12 months. Tablets | Drug | Valsartan 80 mg + Paravastin 40 mg |
| simvastatinAlso: Zocor, MK073340 mg simvastatin. Duration: 12 months. Tablets | Drug | Valsartan 80 mg + Simvastatin 40 mg |
| ezetimibe (+) simvastatinAlso: vytorin, MK0653Aezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets | Drug | Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg |
Primary outcome
Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients
Time frame: 6 Month(s)
Left ventricular hypertrophy reduction was to be measured by echocardiography.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valsartan, pravastatin and simvastatin in people with Hypertension, run by Fundación Lindavista del Corazón AC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients (time frame: 6 Month(s)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.