Elevated LDL CholesterolPhase 2NCT01362218
Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol
A Phase 2 study testing Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) and Simvastatin, ramipril, acetylsalicylic acid in people with Elevated LDL Cholesterol, run by Ferrer Internacional S.A. at 1 site in Spain.
Trial summary
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Elevated LDL Cholesterol
- What is being tested?
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) and Simvastatin, ramipril, acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2010to Apr 2012
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 and <75 years.
- Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.
- LDL-cholesterol ≥130 and ≤220 mg/dL.
- Systolic blood pressure ≥120 and <160 mmHg and diastolic blood pressure ≥70 and <100 mmHg.
- Provide written informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.
- Conditions
- Elevated LDL Cholesterol
- Being tested
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), Simvastatin, ramipril, acetylsalicylic acid
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)Drug
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.
Simvastatin, ramipril, acetylsalicylic acidDrug
A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fixed Dose Combination Pill | Experimental | A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) Receives: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) |
| Simvastatin | Active comparator | Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid Receives: Drug: Simvastatin, ramipril, acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.
Measured: Day 56
Secondary outcomes (4)
• Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period.
Measured: Day 56
• Difference in HDL-cholesterol levels between the basal and the final visit of treatment period.
Measured: Day 56
• Difference in total cholesterol levels between the basal and the final visit of treatment period.
Measured: Day 56
• Difference in triglyceride levels between the basal and the final visit of treatment period
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Per sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated LDL CholesterolStudies 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
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferrer Internacional S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362218
- Sponsor's protocol ID
- P-100820-01
- Status last verified
- Apr 2013
- First submitted
- 26 May 2011
- Last updated
- 24 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol
- ClinicalTrials.gov ID
- NCT01362218
- Acronym / sponsor ID
- P-100820-01
- Conditions
- Elevated LDL Cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per sponsor's decision
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 May 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.
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Dose Combination Pill | Experimental | Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) |
| Simvastatin | Active comparator | Drug: Simvastatin, ramipril, acetylsalicylic acidSimvastatin given together with the reference drugs ramipril and acetylsalicylic acid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged ≥18 and <75 years.
- Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.
- LDL-cholesterol ≥130 and ≤220 mg/dL.
- Systolic blood pressure ≥120 and <160 mmHg and diastolic blood pressure ≥70 and <100 mmHg.
- Provide written informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks. | Drug | Fixed Dose Combination Pill |
| Simvastatin, ramipril, acetylsalicylic acidA once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks | Drug | Simvastatin |
Primary outcome
Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.
Time frame: Day 56
4 secondary outcomes
• Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period.
Time frame: Day 56
• Difference in HDL-cholesterol levels between the basal and the final visit of treatment period.
Time frame: Day 56
• Difference in total cholesterol levels between the basal and the final visit of treatment period.
Time frame: Day 56
• Difference in triglyceride levels between the basal and the final visit of treatment period
Time frame: Day 56
Results and safety
The study was stopped early (reason given: Per sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) and Simvastatin, ramipril, acetylsalicylic acid in people with Elevated LDL Cholesterol, run by Ferrer Internacional S.A. at 1 site in Spain.
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 0 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 24 Apr 2013. 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 Spain. 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. 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?
The study was stopped early (reason given: Per sponsor's decision). Results are not available in the source record.
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?
Difference in LDL-cholesterol levels between the basal and the final visit of treatment period. (time frame: Day 56). 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 24 Apr 2013.