NCT00421278

Brief Summary

A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

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

November 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

January 9, 2007

Last Update Submit

January 21, 2016

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effects of the drug, MK 0633, on an inflammatory marker in your blood that may affect the plaque in the arteries, know as atherosclerosis

    4 Weeks

Study Arms (1)

1

EXPERIMENTAL

Arm 1: Drug

Drug: MK0633

Interventions

MK0633DRUG

Single dose MK0633 100mg po in the fed state administered during a 4-wk study.

1

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease
  • Inflammatory marker found in your blood, known as hsCRP \> 0.5 mg/L

You may not qualify if:

  • Age \< 40 or \> 85
  • Female
  • Heart attack, coronary artery bypass, stroke or unstable angina in last 3 months
  • Liver diseased or abnormalities
  • HIV infection
  • Lupus, rheumatoid arthritis, cancer \<5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atherosclerosis

Interventions

MK-0633 p-toluenesulfonate

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2006

Study Completion

January 1, 2007

Last Updated

January 22, 2016

Record last verified: 2016-01