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Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708)

This study has been terminated.
(Slow enrollment [HIGH SCREEN FAILURE RATE])
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00651378
First received: March 31, 2008
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of <2.5 mmol/L. Treatment phase is 6 weeks.


Condition Intervention Phase
Hypercholesterolemia
Atherosclerosis
Coronary Artery Disease
Drug: Rosuvastatin
Drug: Ezetimibe + Atorvastatin
Drug: Double Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Parallel-Group, Multicenter Study to Compare the Efficacy and Safety of "Switching" to Rosuvastatin 10 mg Daily Versus Atorvastatin 10 mg Daily With Ezetimibe 10 mg Daily Versus Doubling the Dose of Atorvastatin to 20 mg Daily in Subjects With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease or Diabetes Mellitus Who Have Not Achieved Study Target LDL-C Goal While Dosing With Atorvastatin 10 mg Daily

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent change in LDL-C level from baseline to the study endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent changes from baseline to the end of treatment in the concentrations of total cholesterol (TC), non-HDL-C, apo B, triglycerides (TG), HDL-C, LDL-C/HDL-C ratio, and TC/HDL-C ratio. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adverse events, laboratory test results, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 87
Study Start Date: September 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin Drug: Rosuvastatin
oral tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily)
Other Name: Crestor
Active Comparator: Ezetimibe + Atorvastatin Drug: Ezetimibe + Atorvastatin
oral tablets: ezetimibe 10 mg plus atorvastatin 10 mg once daily for 6 weeks (add ezetimibe to previous run-in with atorvastatin 10 mg daily)
Other Names:
  • SCH 58235
  • Zetia
  • Lipitor
Active Comparator: Double Atorvastatin Drug: Double Atorvastatin
oral tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily)
Other Name: Lipitor

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years to 75 years of age;
  • Stabilized on atorvastatin 10 mg daily and by subject reported history had taken at least 80% of daily doses for the 4 weeks preceding Visit 1;
  • LDL-C concentration greater than or equal to 2.5 mmol/L to less than or equal to 160 mg/dL (less than or equal to 4.1 mmol/L) based on blood specimens taken at Visit 1, using the Friedewald calculation as described in the Protocol,Section 8.8. (The lipid profiles at Visit 3 (baseline) and all subsequent visits were kept "blinded" until data analysis);
  • Triglyceride concentration of less than 350 mg/dL (less than 3.99 mmol/L) based on blood specimens taken at Visit 1;
  • Documented atherosclerotic disease, CHD, or diabetes mellitus;
  • Liver transaminases (ALT, AST) less than 50% above the upper limit of normal, with no active liver disease, and CPK less than 50% above the upper limit of normal as tested in blood specimens taken at Visit 1;
  • Clinical laboratory tests (CBC, blood chemistries, urinalysis) taken at Visit 1 must have been within normal limits or clinically acceptable to the Investigator;
  • Had been previously prescribed a cholesterol lowering diet and exercise program at least 4 weeks prior to Visit 1 and had been advised to continue the same diet and exercise program during the study;
  • Reported a stable weight history for at least 4 weeks prior to randomization at Visit 3 (baseline visit);
  • 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 willing to continue the same regimen for the duration of the study;
  • Women of childbearing potential (included women who were less than 1 year postmenopausal and women who became sexually active) must have been using an acceptable method of birth control (for example, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or been surgically sterilized (for example, hysterectomy or tubal ligation).
  • Free of any clinically significant diseases other than hyperlipidemia, CHD, or diabetes mellitus that would interfere with study evaluations;
  • Understood and were able to adhere to the dosing and visit schedules, and demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent.

Exclusion Criteria:

  • Consumption greater than 14 alcoholic drinks per week. (A drink is: a can of beer [1/2 pint or 250 ml], glass of wine, or single measure of spirits);
  • Any condition or situation which, in the opinion of the Investigator, might have posed a risk to the subject or interfered with participation in the study;
  • Body mass index (BMI) >= 35 Kg/m^2 at Visit 2 (Screening);
  • Women who were pregnant or nursing;
  • Failure to observe the designated washout periods for any of the prohibited medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00651378     History of Changes
Other Study ID Numbers: P03708
Study First Received: March 31, 2008
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Hypercholesterolemia
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Dyslipidemias
Heart Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Atorvastatin
Ezetimibe
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014