A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol

NCT01004705 | Terminated Phase 2 Results

• 1 other identifier: P-080647-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.

Conditions

Elevated LDL Cholesterol

Keywords

cardiovascular; fixed; dose; combination; pill; LDL; cholesterol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.

  Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2

Study Arms (2)

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)

Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),

Simvastatin

ACTIVE COMPARATOR

Once daily oral dose of Simvastatin 40 mg

Drug: Simvastatin

Interventions

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.

Fixed Dose Combination Pill

Simvastatin DRUG

A once daily oral dose of simvastatin for 12 weeks.

Simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years of age
• Previously untreated LDL cholesterol ≥100 mg/dL and ≤180 mg/dL.
• Provide written informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead

Study Sites (1)

Mount Sinai Medical Center

New York, New York, NY 10029-6574, United States

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Blood Circulation; Aspirin; Simvastatin; Ramipril

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Natalia Oudovenko
• Organization: Ferrer Internacional S.A.

noudovenko-research@ferrergrupo.com

+34 93 509 32 82

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 30, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 31, 2012
• Results First Posted: August 31, 2012

Record last verified: 2012-07

Locations

US (1)