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Per sponsor's decision
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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 the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Simvastatin | Active Comparator | Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid |
|
| 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 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in LDL-cholesterol levels between the basal and the final visit of treatment period. | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| • Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period. | Day 56 | |
| • Difference in HDL-cholesterol levels between the basal and the final visit of treatment period. | Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | Spain |
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| 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 |
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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 |
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| Simvastatin, ramipril, acetylsalicylic acid | Drug | A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks |
|
| • Difference in total cholesterol levels between the basal and the final visit of treatment period. | Day 56 |
| • Difference in triglyceride levels between the basal and the final visit of treatment period | Day 56 |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |