HypertensionPhase 4NCT00704548
Antihypertensive Effect of Simvastatin in Hypertensive Patients
A Phase 4 study testing Simvastatin 40mg in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Simvastatin 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patients with controlled or uncontrolled blood pressure
Who cannot join
- Secondary causes of hypertension;
- Systolic Blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg
- Complain of side effects related to Statins
- Diabetes
- Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease)
- Renal disease (creatinine > 1,5 mgdl).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Miguel Gus, MD, +55512101-8420, mgus@terra.com.br
Miguel Gus, MD
About this study
Official title: Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring
Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile.
The purpose of this study is to determine the effect of Simvastatin on the blood pressure
Read the detailed description
This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.
- Conditions
- Hypertension
- Being tested
- Simvastatin 40mg, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 40mgDrug
Simvastatin once daily, orally in the morning period, during eigth weeks
PlaceboDrug
Placebo once daily, orally in the morning period, during eigth weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Simvastatin 40 mg Receives: Drug: Simvastatin 40mg |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM)
Measured: Eigth weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Miguel Gus, MD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704548
- Sponsor's protocol ID
- 08014
- Status last verified
- Jun 2009
- First submitted
- 23 Jun 2008
- Last updated
- 26 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT00704548
- Acronym / sponsor ID
- 08014
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile.
The purpose of this study is to determine the effect of Simvastatin on the blood pressure
Detailed description
This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Simvastatin 40mgSimvastatin 40 mg |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypertensive patients with controlled or uncontrolled blood pressure
Key exclusion criteria (6 listed)
- Secondary causes of hypertension;
- Systolic Blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg
- Complain of side effects related to Statins
- Diabetes
- Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease)
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 |
|---|---|---|
| Simvastatin 40mgSimvastatin once daily, orally in the morning period, during eigth weeks | Drug | 1 |
| PlaceboPlacebo once daily, orally in the morning period, during eigth weeks | Drug | 2 |
Primary outcome
Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM)
Time frame: Eigth weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2009.
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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.
Miguel Gus, MD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin 40mg in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Gus, MD (+55512101-8420, mgus@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM) (time frame: Eigth weeks). 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 Jun 2009.