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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Simvastatin | Active Comparator | Once daily oral dose of Simvastatin 40 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | New York | New York | NY 10029-6574 | United States |
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126 subjects were screened, 47 met eligibility requirements and 44 entered the run-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-randomization Run-In | Screening period with ramipril 2.5 mg |
| FG001 | Combination Pill Then Simvastatin | After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-In |
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| Simvastatin | Drug | A once daily oral dose of simvastatin for 12 weeks. |
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| Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2 |
| FG002 | Simvastatin Then Combination Pill | After randomization, in Period 1 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 1 (12 Weeks) |
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| Washout Period (6 Weeks) |
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| Period 2 (12 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Patients | All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol population | Posted | Mean | Standard Deviation | mg/dL | Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2 |
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| Secondary | 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. | Per Protocol population | Posted | Mean | Standard Deviation | mg/dL | Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2 |
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36 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-randomization Run-In | Screening period with ramipril 2.5 mg | 0 | 44 | 0 | 44 | ||
| EG001 | Combination Pill | Combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks | 0 | 31 | 1 | 31 | ||
| EG002 | Simvastatin | Once daily oral dose of 40 mg simvastatin for 12 weeks | 0 | 31 | 2 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood phosphokinase creatine increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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Early termination leading to small numbers of subjects analyzed.
Publication must be agreed upon with the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalia Oudovenko | Ferrer Internacional S.A. | +34 93 509 32 82 | noudovenko-research@ferrergrupo.com |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001775 | Blood Circulation |
| D001241 | Aspirin |
| D019821 | Simvastatin |
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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