Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

Study Overview
=================
Brief 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 subjects will be screened, 266 randomized in order about 238 subjects to finish the 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

Conditions
-----------------
Elevated LDL Cholesterol

Intervention / Treatment
-----------------
* Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
* Drug: Simvastatin, ramipril, acetylsalicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed Dose Combination Pill<br>A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) | Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)<br>* A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.<br>|
| Active Comparator: Simvastatin<br>Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid | Drug: Simvastatin, ramipril, acetylsalicylic acid<br>* A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in LDL-cholesterol levels between the basal and the final visit of treatment period. |  | Day 56 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| • 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 |