Pre-diabetesPPCVDNCT01364675
Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects
A study testing Metformin+Enalapril+Simvastatin in people with Pre-diabetes and Pre-hypertension, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Pre-hypertension
- What is being tested?
- Metformin+Enalapril+Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,900 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Dec 2016
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pre-diabetes
- Pre-hypertensives
- LDL-Cholesterol >= 100 < 190 mg/dl
- BMI >= 23
- Estimated GFR >= 60 ml/min/1.73 m2 (MDRD equation)
- Willing to participate and provide written inform consent
Who cannot join
- Current involved in other studied medications
- Regular use of corticosteroids
- Current use of weight loss medication
- History of renal disease
- Active liver disease including jaundice, chronic hepatitis with ALT >= 2.5 the upper normal limit
- Active malignancy
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- Major psychiatric disorder
- Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing's syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, antipsychotics)
- Nursing women, pregnant women, or those that plan to become pregnant in the study period
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ubon ratchathani Public Health Office
Muang District, Changwat Ubon Ratchathani, 34000
Phisitt Vejakama, M.D.
About this study
Official title: Primary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial
The purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.
Read the detailed description
The risks of CVD are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. Evidence on the effectiveness of drug interventions to lower CVD events in pre-clinical stage population has been scant.
- Conditions
- Pre-diabetes, Pre-hypertension
- Being tested
- Metformin+Enalapril+Simvastatin, Placebo tablet
- Keywords
- Impaired fasting glucose, Impaired glucose tolerance, Pre-diabetes, Pre-hypertensives, Cardiovascular events
- Medical subject headings
- Glucose Intolerance, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin+Enalapril+SimvastatinDrug
Also called Poly-pill
Poly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years
Placebo tabletDrug
Also called Placebo
Identical Placebo Tablet
| Study group | Role | What they receive |
|---|---|---|
| Metformin+Enalapril+Simvastatin | Experimental | Not described Receives: Drug: Metformin+Enalapril+Simvastatin |
| Placebo tablet | Placebo comparator | Not described Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Events
Fatal or Non-fatal Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization, Fatal or Non-fatal Stroke, Amputation of Lower Extremities (non-traumatic cause)
Measured: 4-year
Secondary outcomes (4)
Micro-vascular Complications
Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy
Measured: 4-year
Cumulative Incidence of Diabetes
Measured: 4-year
Cumulative Incidence of Hypertension
Measured: 4-year
Incidence of Individual Cardiovascular Disease
Coronary Artery Disease - Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization
Stroke- Cerebral Hemorrhage, Cerebral Infarction, Subarachnoid Hemorrhage
Peripheral Artery Disease- Leg amputation, endovascular or surgical intervention in leg arteries
Measured: 4-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ubon Ratchathani Public Health Office, Thailand, National Health Security Office, Thailand, The Government Pharmaceutical Organization
- Investigators
- Phisitt Vejakama, M.D., Principal investigator, Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364675
- Sponsor's protocol ID
- 12011
- Acronym
- PPCVD
- Status last verified
- May 2011
- First submitted
- 31 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01364675
- Acronym / sponsor ID
- PPCVD / 12011
- Conditions
- Pre-diabetes, Pre-hypertension
- Keywords
- Impaired fasting glucose, Impaired glucose tolerance, Pre-diabetes, Pre-hypertensives, Cardiovascular events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,900 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Ubon Ratchathani Public Health Office, Thailand, National Health Security Office, Thailand, The Government Pharmaceutical Organization
- Study start
- Jan 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Jun 2011 (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.
The purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.
Detailed description
The risks of CVD are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. Evidence on the effectiveness of drug interventions to lower CVD events in pre-clinical stage population has been scant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin+Enalapril+Simvastatin | Experimental | Drug: Metformin+Enalapril+Simvastatin |
| Placebo tablet | Placebo comparator | Drug: Placebo tablet |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pre-diabetes
- Pre-hypertensives
- LDL-Cholesterol >= 100 < 190 mg/dl
- BMI >= 23
- Estimated GFR >= 60 ml/min/1.73 m2 (MDRD equation)
Key exclusion criteria (9 listed)
- Current involved in other studied medications
- Regular use of corticosteroids
- Current use of weight loss medication
- History of renal disease
- Active liver disease including jaundice, chronic hepatitis with ALT >= 2.5 the upper normal limit
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 |
|---|---|---|
| Metformin+Enalapril+SimvastatinAlso: Poly-pillPoly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years | Drug | Metformin+Enalapril+Simvastatin |
| Placebo tabletAlso: PlaceboIdentical Placebo Tablet | Drug | Placebo tablet |
Primary outcome
Cardiovascular Events
Time frame: 4-year
Fatal or Non-fatal Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization, Fatal or Non-fatal Stroke, Amputation of Lower Extremities (non-traumatic cause)
4 secondary outcomes
Micro-vascular Complications
Time frame: 4-year
Cumulative Incidence of Diabetes
Time frame: 4-year
Cumulative Incidence of Hypertension
Time frame: 4-year
Incidence of Individual Cardiovascular Disease
Time frame: 4-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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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.
Phisitt Vejakama, M.D. principal investigator
Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin+Enalapril+Simvastatin in people with Pre-diabetes and Pre-hypertension, run by Ramathibodi Hospital at 1 site in Thailand.
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 6 inclusion and 9 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 2 Jun 2011. 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 Thailand. 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.
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 Phisitt Vejakama, M.D. (66849562882, toughcountrydoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Events (time frame: 4-year). 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 2 Jun 2011.