MK0859 Dose-Ranging Study (0859-003)

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of MK-0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00325455
• Other study ID #: 0859-003
• Secondary ID: 2006_006
• Status: Terminated
• Phase: Phase 2
• First received: May 11, 2006
• Last updated: February 27, 2015
• Start date: June 2006
• Est. completion date: March 2007

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: March 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol

Exclusion Criteria:

• Patients with CHD or CHD-equivalent disease (except diabetes)

• Diabetics on statins

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipoproteinemia Type V
• Mixed Hyperlipemia

Intervention

Drug:
• MK0859

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Dansky HM, Bloomfield D, Gibbons P, Liu S, Sisk CM, Tribble D, McKenney JM, Littlejohn TW 3rd, Mitchel Y. Efficacy and safety after cessation of treatment with the cholesteryl ester transfer protein inhibitor anacetrapib (MK-0859) in patients with primary — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the cholesterol changing effects of MK0859
Secondary	Acceptable safety profile