Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

NCT00319449 | Completed Phase 4 Results

• 1 other identifier: P04060
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.

Conditions

Hypercholesterolemia; Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg

  12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - \[HDL-C + TG/5\]) before and after treatment.

  Baseline and 6 weeks

Secondary Outcomes (2)

• Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)

  6 weeks post treatment

• High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg

  6 weeks post treatment

Study Arms (2)

Ezetimibe 10 mg

EXPERIMENTAL

Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.

Drug: Ezetimibe; Drug: Atorvastatin 10 mg

Placebo 10 mg

PLACEBO COMPARATOR

Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.

Drug: Placebo; Drug: Atorvastatin 10 mg

Interventions

Ezetimibe DRUG

10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin

Ezetimibe 10 mg

Placebo DRUG

10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin

Placebo 10 mg

Atorvastatin 10 mg DRUG

10 mg/day atorvastatin, orally, (ongoing treatment in participants)

Ezetimibe 10 mg; Placebo 10 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have an LDL-C concentration \>= 3.3 mmol/L (130 mg/dL) to \<= 4.9 mmol/L (190 mg/dL) using the Freidewald calculation.
• Participants must have triglyceride concentrations of \< 3.99 mmol/L (350 mg/dL).
• Participants must have two or more coronary heart disease risk factors listed below:
• Current cigarette smoking
• Hypertension (BP \>= 140/90 mmHg or on antihypertensive medication)
• Low HDL cholesterol (\< 40 mg/dL)
• Family history of premature CHD (CHD in male first degree relative \< 55 years; CHD in female first degree relative \< 65 years)
• Age (Men \>= 45 years; women \>= 55 years)
• Participant must be currently taking atorvastatin 10 mg daily and by history has taken 80% of daily doses for the 6 weeks prior to participating.
• Participants must have liver transaminases (ALT, AST) \< 50% above the upper limit of normal, with no active liver disease, and CK \< 50% above the upper limit of normal.
• Participants must have maintained a cholesterol lowering diet, exercise program, and stable weight for at least 4 weeks prior to the study and be willing to continue the same diet and exercise program during the study.
• Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded:
• Body mass index (BMI = weight \[kg\]/height\*\*2\[m\]) is \>= 30 Kg/m\*\*2.
• Consume \> 14 alcoholic drinks per week.
• Women who are pregnant or nursing.
• Congestive heart failure defined by NYHA as Class III or IV.
• Uncontrolled cardiac arrhythmia.
• Coronary heart disease (CHD).
• Unstable or severe peripheral artery disease within 3 months of participating
• Uncontrolled hypertension (treated or untreated) with systolic blood pressure \> 160 mm Hg or diastolic \> 100 mm Hg.
• Type I or Type II diabetes mellitus.
• Secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism.
• Impaired renal function (creatinine \> 2.0 mg/dL) or nephrotic syndrome.
• Known HIV positive.
• Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).
• History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.

Sponsors & Collaborators

• Organon and Co: lead
• PT. Schering-Plough. Tbk Indonesia: collaborator

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Artery Disease

Interventions

Ezetimibe; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: April 27, 2006
• Study Start: September 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 9, 2022
• Results First Posted: May 10, 2011

Record last verified: 2022-02