Back to resultsEffect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)
Primary Purpose
Hypercholesteremia, Hyperlipidemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK-0524A
ER Niacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesteremia focused on measuring Primary Hypercholesteremia, Mixed Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- Patient is appropriate candidate for niacin therapy
- Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1
- Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1
- Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1
- Patient has TG <500 mg/dL (5.65 mmol/L) at V1
- A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria
- ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA
Exclusion Criteria:
- Patients with unstable doses of medications
- Pregnant or lactating women, or women intending to become pregnant are excluded
- Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
- Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Placebo → MK-0524A 2g
Placebo → Extended Release (ER)-Niacin 2g
MK-0524A 2g
Arm Description
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days).
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days)
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks).
Outcomes
Primary Outcome Measures
Global Flushing Severity Score (GFSS) during 7 days of treatment
Secondary Outcome Measures
Percentage of Participants Who Experience at Least 1 Adverse Event
Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event
Full Information
NCT ID
NCT00376584
First Posted
September 14, 2006
Last Updated
February 15, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00376584
Brief Title
Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)
Official Title
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesteremia, Hyperlipidemia
Keywords
Primary Hypercholesteremia, Mixed Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
825 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo → MK-0524A 2g
Arm Type
Placebo Comparator
Arm Description
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days).
Arm Title
Placebo → Extended Release (ER)-Niacin 2g
Arm Type
Active Comparator
Arm Description
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days)
Arm Title
MK-0524A 2g
Arm Type
Experimental
Arm Description
Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks).
Intervention Type
Drug
Intervention Name(s)
MK-0524A
Intervention Type
Drug
Intervention Name(s)
ER Niacin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Global Flushing Severity Score (GFSS) during 7 days of treatment
Time Frame
during 7 days of treatment
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Experience at Least 1 Adverse Event
Time Frame
up to 10 weeks
Title
Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event
Time Frame
up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is appropriate candidate for niacin therapy
Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1
Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1
Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1
Patient has TG <500 mg/dL (5.65 mmol/L) at V1
A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria
ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA
Exclusion Criteria:
Patients with unstable doses of medications
Pregnant or lactating women, or women intending to become pregnant are excluded
Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)
We'll reach out to this number within 24 hrs