- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00536237
MK0524A Phase IIb Study (0524A-011)(COMPLETED)
August 24, 2015 updated by: Merck Sharp & Dohme LLC
Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients
Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.
Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening
- Must be willing to complete electronic diary
Exclusion Criteria:
- Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
- You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
- You consume more than 14 alcoholic drinks per week or more than 2 drinks per day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the effect of MK0524A on lipids and blood glucose
Time Frame: 17 Weeks
|
17 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish the dose for limiting flushing symptoms induced by NIASPAN (R)
Time Frame: 17 Weeks
|
17 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
September 26, 2007
First Submitted That Met QC Criteria
September 26, 2007
First Posted (Estimate)
September 27, 2007
Study Record Updates
Last Update Posted (Estimate)
August 25, 2015
Last Update Submitted That Met QC Criteria
August 24, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0524A-011
- MK0524A-011
- 2007_618
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Flushing
-
Imperial College LondonAstraZeneca; Medical Research Council; National Institute for Health Research...CompletedMenopausal FlushingUnited Kingdom
-
University Hospital Inselspital, BerneRecruitingPostmenopausal | Postmenopausal FlushingSwitzerland
-
Northwestern UniversityActive, not recruiting
-
Rio de Janeiro State UniversityCompletedEndothelial Dysfunction | Cardiovascular Risk Factor | Postmenopausal FlushingBrazil
-
Skin Laser & Surgery SpecialistsGalderma R&DTerminatedErythema and Flushing Associated With Rosacea
-
Eastern Virginia Medical SchoolAbbottCompleted
-
University of PennsylvaniaAbbottCompleted
-
C. R. BardTerminated
Clinical Trials on Comparator: niacin / Duration of Treatment: 17 Weeks
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedHypercholesterolemia
-
Merck Sharp & Dohme LLCCompleted
-
Organon and CoCompleted
-
H. Lundbeck A/STerminated
-
Organon and CoCompleted
-
Merck Sharp & Dohme LLCCompletedComplicated Intra-Abdominal Infections
-
Organon and CoCompleted
-
H. Lundbeck A/STerminated
-
Organon and CoCompletedBenign Prostatic Hyperplasia