To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00398294
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: MK0733, simvastatin / Duration of Treatment: 12 Weeks	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Single-Arm, Prospective Study to Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet in Patients With Hypercholesterolemia
• Actual Study Start Date: May 1, 2005
• Actual Primary Completion Date: Apr 4, 2006
• Actual Study Completion Date: Apr 4, 2006

Outcome Measures

Primary Outcome Measures

1. Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female patient, >18 years of age

• Patients with hypercholesterolemia who meet the following lipid criteria:

1. primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl

2. secondary cholesterolemia (patients with cad, dm): ldl-c>=130 mg/dl

• The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study

Exclusion Criteria:

• Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris

• Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1

• Uncontrolled hypertension with systolic blood pressure > 160 mmhg or diastolic > 100 mmhg at visit 1.

• Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merck Sharp & Dohme (I.A.) Corp.	Taipei		Taiwan	106

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00398294
• Other Study ID Numbers: 0733-264; 2006_044
• First Posted: Nov 10, 2006
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Hypercholesterolemia; Simvastatin

Study Results

No Results Posted as of Feb 17, 2022