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

Stopped early · Phase 2

Conditions studied: Elevated LDL Cholesterol

In brief

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.

Key facts

Study ID

NCT01004705

Run by

Ferrer Internacional S.A.

People needed

36

Starts

2009-09-01

Expected to finish

2011-03-01

Last updated by the study team

2012-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Serum creatinine >2 mg/dL.
• Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
• Hemoglobin ≤12 g/dL (120 g/L) for male subjects or ≤10 g/dL (100 g/L) for female subjects.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN.
• Total bilirubin ≥1.5 x ULN.
• Serum triglyceride concentration ≥400 mg/dL.
• Subjects not using effective contraception methods (intra uterine device [IUD] and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter.
• Pregnant, lactating, breastfeeding, or intends to become pregnant during the course of the study (females only). All women must have a negative urine pregnancy test at the Screening Visit, be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or have a postmenopausal status (no menses) for at least one year.
• Contraindications to or known or suspected hypersensitivity to aspirin, simvastatin or ramipril or their excipients.
• Presence of mental illness limiting the capacity for self-care.

Where it is running

• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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