Cardiovascular DiseasePhase 2PolypillNCT00603590
Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease
A Phase 2 study testing Polypill in people with Cardiovascular Disease and Hypertension, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths attributed to cardiovascular events. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Hypertension, Hyperlipidemia
- What is being tested?
- Polypill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 475 participants
- Where
- 1 siteIran
- Study dates
- Nov 2006to Jul 2008
- Phase
- Phase 2
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year.
Who cannot join
- Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)
- Already taking antihypertensive drugs, aspirin or statins
- Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.
- Blood pressure >160/100 mm Hg
- Total Cholesterol > 240 mg/dL (or LDL >190 mg/dL)
- Probable diabetes: HbA1c >6.0
Show all 24Show fewer
- Contraindication to a component of the Polypill
- Contraindications to aspirin
- Previous history of allergy to aspirin
- History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months
- Contraindications to statins
- Liver failure Contraindications to further blood pressure lowering
- Systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤70 mm Hg
- Symptomatic postural hypotension
- Difference between mean seated BP and standing BP greater than 20 mm Hg
- Contraindications to thiazide
- Uric acid >8 for men and uric acid >6 for women / gout (~10%)
- Creatinine >1.2 mg/dl
- Other predominant medical problem that may limit compliance with study treatment including:
- History of alcohol abuse: more than 60cc for women and more than 80cc for men
- History of drug abuse: IV drug abuser or eating or smoking more than 4 times a week
- Limiting psychiatric illness (eg: mania, schizophrenia, severe depression, psychosis or dementia)
- Limiting physical disability sufficient to prevent subject from walking
- Other life-threatening condition such as cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Heart Polypill in Primary Prevention of Cardiovascular Disease - Safety and Efficacy
Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths attributed to cardiovascular events. Cardiovascular diseases will become an increasing problem as the Iranian population ages.
In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a single preparation. They proposed that this treatment should be offered to all persons at high risk of cardiovascular disease whether or not they have elevated blood pressure or elevated serum lipid concentrations.
Read more
This pilot study aims to investigate the safety and efficacy of fixed-dose combination therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would not currently be considered eligible for antihypertensive treatment or for lipid lowering treatment.
Methods:
This is a double-blind randomized controlled trial. The intervention group will be assigned to take a tablet consisting of a single daily tablet comprising Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be assigned to an identical placebo.
The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80 (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore lipid lowering therapy are excluded.
It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for the purpose of sample size calculation is change in systolic blood pressure. Additional outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence of adverse events.
- Conditions
- Cardiovascular Disease, Hypertension, Hyperlipidemia, Heart Disease
- Being tested
- Polypill, Placebo drug
- Keywords
- Cardiovascular disease, primary prevention, Polypill, efficacy, safety, ADR, Diabetes, Adherence, Compliance
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Hyperlipidemias, Heart Diseases, Diabetes Mellitus, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolypillDrug
Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily
Placebo drugDrug
Inactive tablet Once a day Identical in appearance to intervention drug
| Study group | Role | What they receive |
|---|---|---|
| Polypill | Experimental | Fixed dose combination therapy with Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg Receives: Drug: Polypill |
| Control | Placebo comparator | Identical placebo Receives: Drug: Placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Systolic blood pressure. Mean of two seated measurements.
Measured: One year
Secondary outcomes (2)
Diastolic Blood Pressure
Mean of two seated diastolic blood pressures
Measured: One year
LDL Cholesterol
Serum LDL cholesterol
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startNov 2006
- Primary completionJun 2008
- Study completionJul 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Investigators
- Reza Malekzadeh, M.D., Study chair, Tehran University of Medical SciencesFatemeh Malekzadeh, M.D., Principal investigator, Tehran University of Medical SciencesMansoor Rastegarpanah, Ph.D., Principal investigator, Tehran University of Medical SciencesKar K Cheng, PhD, Study chair, University of BirminghamTom P Marshall, PhD, Principal investigator, University of BirminghamAkram Pourshams, PhD, Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603590
- Sponsor's protocol ID
- 301/148
- Other IDs
- CCT-NAPN 15388
- Acronym
- Polypill
- Status last verified
- Sep 2009
- First submitted
- 1 Jan 2008
- Last updated
- 2 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rastegarpanah M, Malekzadeh F, Thomas GN, Mohagheghi A, Cheng KK, Marshall T. A new horizon in primary prevention of cardiovascular disease, can we prevent heart attack by "heart polypill"? Arch Iran Med. 2008 May;11(3):306-13. No abstract available.
PubMed 18426322
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Heart Polypill in Primary Prevention of Cardiovascular Disease - Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00603590
- Acronym / sponsor ID
- Polypill / 301/148
- Conditions
- Cardiovascular Disease, Hypertension, Hyperlipidemia, Heart Disease
- Keywords
- Cardiovascular disease, primary prevention, Polypill, efficacy, safety, ADR, Diabetes, Adherence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- Nov 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Posted 23 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths attributed to cardiovascular events. Cardiovascular diseases will become an increasing problem as the Iranian population ages.
In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a single preparation. They proposed that this treatment should be offered to all persons at high risk of cardiovascular disease whether or not they have elevated blood pressure or elevated serum lipid concentrations.
This pilot study aims to investigate the safety and efficacy of fixed-dose combination therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would not currently be considered eligible for antihypertensive treatment or for lipid lowering treatment.
Methods:
This is a double-blind randomized controlled trial. The intervention group will be assigned to take a tablet consisting of a single daily tablet comprising Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be assigned to an identical placebo.
The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80 (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore lipid lowering therapy are excluded.
It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for the purpose of sample size calculation is change in systolic blood pressure. Additional outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence of adverse events.
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 |
|---|---|---|
| Polypill | Experimental | Drug: PolypillFixed dose combination therapy with Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg |
| Control | Placebo comparator | Drug: Placebo drugIdentical placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year.
Key exclusion criteria (24 listed)
- Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina)
- Already taking antihypertensive drugs, aspirin or statins
- Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins.
- Probable diabetes: HbA1c >6.0
- Contraindication to a component of the Polypill
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 |
|---|---|---|
| PolypillFixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily | Drug | Polypill |
| Placebo drugInactive tablet Once a day Identical in appearance to intervention drug | Drug | Control |
Primary outcome
Systolic Blood Pressure
Time frame: One year
Systolic blood pressure. Mean of two seated measurements.
2 secondary outcomes
Diastolic Blood Pressure
Time frame: One year
LDL Cholesterol
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18426322Rastegarpanah M, Malekzadeh F, Thomas GN, Mohagheghi A, Cheng KK, Marshall T. A new horizon in primary prevention of cardiovascular disease, can we prevent heart attack by "heart polypill"? Arch Iran Med. 2008 May;11(3):306-13. No abstract available.
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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.
Reza Malekzadeh, M.D. study chair
Tehran University of Medical Sciences
Fatemeh Malekzadeh, M.D. principal investigator
Tehran University of Medical Sciences
Mansoor Rastegarpanah, Ph.D. principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polypill in people with Cardiovascular Disease and Hypertension, run by Tehran University of Medical Sciences at 1 site in Iran.
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 24 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: finished, as of the sponsor's last update on 2 Oct 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Jun 2009). 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?
Systolic Blood Pressure (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00603590, which also lists 1 linked publication.
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 Oct 2009.