Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

Elevated LDL Cholesterol Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01362218
• Other study ID #: P-100820-01
• Status: Terminated
• Phase: Phase 2
• First received: May 26, 2011
• Last updated: April 23, 2013
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Ferrer Internacional S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical 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 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Elevated LDL Cholesterol

Intervention

Drug:
• 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.
• Simvastatin, ramipril, acetylsalicylic acid
A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Ferrer Internacional S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.		Day 56	No
Secondary	• Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period.		Day 56	No
Secondary	• Difference in HDL-cholesterol levels between the basal and the final visit of treatment period.		Day 56	No
Secondary	• Difference in total cholesterol levels between the basal and the final visit of treatment period.		Day 56	No
Secondary	• Difference in triglyceride levels between the basal and the final visit of treatment period		Day 56	No