NCT00565292

Brief Summary

This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL cholesterol in blood) This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

1 month

First QC Date

November 27, 2007

Last Update Submit

February 24, 2015

Conditions

HypercholesterolemiaHyperlipidemia

Interventions

MK0859DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is between 18 and 75 years of age
  • Patient can be on a stable diet for the study
  • Patient has a stable weight for more then 6 weeks before the study and has not participated in a weight loss program

You may not qualify if:

  • Patient has chronic heart failure or a history of heart disease
  • Patient has blood, digestive, or central nervous system disorders
  • Patient is pregnant or nursing
  • Patient is HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Krishna R, Anderson MS, Bergman AJ, Jin B, Fallon M, Cote J, Rosko K, Chavez-Eng C, Lutz R, Bloomfield DM, Gutierrez M, Doherty J, Bieberdorf F, Chodakewitz J, Gottesdiener KM, Wagner JA. Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomised placebo-controlled phase I studies. Lancet. 2007 Dec 8;370(9603):1907-14. doi: 10.1016/S0140-6736(07)61813-3.

    PMID: 18068514DERIVED

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemias

Interventions

anacetrapib

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 29, 2007

Study Start

July 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

February 25, 2015

Record last verified: 2015-02