Elevated LDL CholesterolPhase 2NCT01004705
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
A Phase 2 study testing Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), and Simvastatin in people with Elevated LDL Cholesterol, run by Ferrer Internacional S.A. at 1 site in United States.
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 simvastatin given alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated LDL Cholesterol
- What is being tested?
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), and Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥18 years of age
- Previously untreated LDL cholesterol ≥100 mg/dL and ≤180 mg/dL.
- Provide written informed consent.
Who cannot join
- Subjects with a medical condition requiring chronic pharmacological treatment
- On direct questioning and physical examination have evidence of any clinically significant chronic disease, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
- On direct questioning and physical examination have a medical history or evidence of abuse of drugs.
- Medical history of gastrointestinal bleeding or gastric or duodenal ulcer.
- Systolic pressure ≥140 mmHg or diastolic pressure >89 mmHg requiring hypotensive medication.
- Presence of secondary dyslipidemia.
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- Previous use of cholesterol lowering medication.
- Previous coronary artery bypass graft (CABG).
- Previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
- Presence of severe congestive heart failure (New York Heart Classification [NYHC] III IV).
- Presence of untreated or uncontrolled thyroid disease.
- Past or current medical history of asthma or aspirin induced asthma
- Previous hypersensitivity to ACE inhibitors (eg angioedema or cough).
- Previous hypersensitivity to ARBs.
- History of unstable angina.
- Serum creatinine >2 mg/dL.
- Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
- Hemoglobin ≤12 g/dL (120 g/L) for male subjects or ≤10 g/dL (100 g/L) for female subjects.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN.
- Total bilirubin ≥1.5 x ULN.
- Serum triglyceride concentration ≥400 mg/dL.
- Subjects not using effective contraception methods (intra uterine device [IUD] and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter.
- Pregnant, lactating, breastfeeding, or intends to become pregnant during the course of the study (females only). All women must have a negative urine pregnancy test at the Screening Visit, be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or have a postmenopausal status (no menses) for at least one year.
- Contraindications to or known or suspected hypersensitivity to aspirin, simvastatin or ramipril or their excipients.
- Presence of mental illness limiting the capacity for self-care.
- Presence of major systemic illnesses: renal disease, liver disease, neurological or psychiatric disease.
- Participation, in the 30 days preceding enrolment into the study, in any other clinical study in which investigational or marketed drugs were employed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, NY 10029-6574
About this study
Official title: Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Study of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril in Subjects With Elevated 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 simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.
- Conditions
- Elevated LDL Cholesterol
- Being tested
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),, Simvastatin
- Keywords
- cardiovascular, fixed, dose, combination, pill, LDL, cholesterol
- 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 12 weeks.
SimvastatinDrug
A once daily oral dose of simvastatin for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fixed Dose Combination Pill | Experimental | Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg ramipril) Receives: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), |
| Simvastatin | Active comparator | Once daily oral dose of Simvastatin 40 mg Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.
Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.
Measured: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
Secondary outcomes (1)
The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.
Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.
Measured: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionMar 2011
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 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01004705
- Sponsor's protocol ID
- P-080647-01
- Status last verified
- Jul 2012
- First submitted
- 23 Oct 2009
- Last updated
- 31 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Study of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril in Subjects With Elevated LDL Cholesterol
- ClinicalTrials.gov ID
- NCT01004705
- Acronym / sponsor ID
- P-080647-01
- Conditions
- Elevated LDL Cholesterol
- Keywords
- cardiovascular, fixed, dose, combination, pill, LDL, cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 31 Aug 2012
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 simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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),Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg ramipril) |
| Simvastatin | Active comparator | Drug: SimvastatinOnce daily oral dose of Simvastatin 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects ≥18 years of age
- Previously untreated LDL cholesterol ≥100 mg/dL and ≤180 mg/dL.
- Provide written informed consent.
Key exclusion criteria (27 listed)
- Subjects with a medical condition requiring chronic pharmacological treatment
- On direct questioning and physical examination have evidence of any clinically significant chronic disease, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
- On direct questioning and physical examination have a medical history or evidence of abuse of drugs.
- Medical history of gastrointestinal bleeding or gastric or duodenal ulcer.
- Systolic pressure ≥140 mmHg or diastolic pressure >89 mmHg requiring hypotensive medication.
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 12 weeks. | Drug | Fixed Dose Combination Pill |
| SimvastatinA once daily oral dose of simvastatin for 12 weeks. | Drug | Simvastatin |
Primary outcome
The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.
Time frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.
1 secondary outcome
The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.
Time frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- 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.
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 in people with Elevated LDL Cholesterol, run by Ferrer Internacional S.A. at 1 site in United States.
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 3 inclusion and 27 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 31 Aug 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2012). 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?
The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period. (time frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2). 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 31 Aug 2012.