Clinical Trials Logo
  1. Home
  2. Hypercholesterolemia
  3. NCT00132717
  4. Details
NCT00132717 Clinical Trial

A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)

Hypercholesterolemia Clinical Trial

Official title:
An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination Tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00132717
Other study ID # 0653A-808
Secondary ID 2004_046
Status Completed
Phase Phase 3
First received
Last updated
Start date January 1, 2005
Est. completion date June 1, 2007

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of an investigational cholesterol-lowering drug in patients who are currently taking an approved medication for hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart problem.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date June 1, 2007
Est. primary completion date June 1, 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients greater than 18 years old, who were admitted to a hospital for an investigation of a heart problem and are currently receiving an approved medication to lower cholesterol Exclusion Criteria: - Patients who have congestive heart failure (CHF), uncontrolled high blood pressure, poorly controlled blood sugar, impaired kidney function, or HIV.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653A (ezetimibe [+] simvastatin)

• Comparator: atorvastatin

• Comparator: fluvastatin

• Comparator: lovastatin

• Comparator: pravastatin

• Comparator: rosuvastatin

• Comparator: simvastatin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (2)

Brudi P, Reckless JP, Henry DP, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO. Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event. Cardiology. 2009;113(2):89-97. doi: 10.1159/000172795. Epub 2008 Nov 15. — View Citation

Reckless JP, Henry P, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO, Lis K, Brudi P, Allen C. Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. Int J Clin Pract. 2008 Apr;62(4):539-54. doi: 10.1111/j.1742-1241.2008.01697.x. Epub 2008 Feb 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the effectiveness of MK0653A compared to doubling the statin dose as shown by the low-density lipoprotein cholesterol (LDL-C) values achieved after 12 weeks of treatment After 12 weeks of treatment
Secondary To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks After 12 weeks of treatment
See also
  Status Clinical Trial Phase
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Recruiting NCT03947866 - Ezetimibe-Rosuvastatin Evaluation Study
Completed NCT01709513 - Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) Phase 3
Completed NCT01212900 - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression Phase 4
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Completed NCT02550288 - A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383) Phase 3
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT04485793 - Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia N/A
Completed NCT02341924 - Validating the "Foods for Health" Portfolio of Functional Food Products N/A
Active, not recruiting NCT02223793 - Vascular Lifestyle-Intervention and Screening in Pharmacy N/A
Completed NCT01941836 - Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients Phase 2
Completed NCT01934608 - The Effect of Synching Prescription Refills on Adherence N/A
Recruiting NCT01705873 - Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen N/A
Completed NCT01670734 - Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects Phase 1
Completed NCT01678521 - Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients N/A
Completed NCT01370590 - A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1) Phase 3
Completed NCT01370603 - A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1) Phase 3
Completed NCT01446679 - Special Drug Use-Results Survey of Lipitor Tablets N/A
Completed NCT01575171 - Using Nudges to Implement Comparative Effectiveness N/A
Completed NCT01478789 - Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans N/A