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Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00376584
First received: September 14, 2006
Last updated: October 5, 2015
Last verified: October 2015

September 14, 2006
October 5, 2015
July 2006
January 2007   (final data collection date for primary outcome measure)
Global Flushing Severity Score (GFSS) during 7 days of treatment [ Time Frame: during 7 days of treatment ] [ Designated as safety issue: No ]
Global Flushing Severity Score (GFSS) during 7 days of treatment
Complete list of historical versions of study NCT00376584 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Experience at Least 1 Adverse Event [ Time Frame: up to 10 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event [ Time Frame: up to 10 weeks ] [ Designated as safety issue: Yes ]
Safety/Tolerability
Not Provided
Not Provided
 
Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hypercholesteremia
  • Hyperlipidemia
  • Drug: MK-0524A
  • Drug: ER Niacin
  • Drug: Placebo
  • Placebo Comparator: Placebo → MK-0524A 2g
    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).
    Interventions:
    • Drug: MK-0524A
    • Drug: Placebo
  • Active Comparator: Placebo → Extended Release (ER)-Niacin 2g
    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)
    Interventions:
    • Drug: ER Niacin
    • Drug: Placebo
  • Experimental: MK-0524A 2g
    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: Drug: MK-0524A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
825
January 2007
January 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Austria,   Germany,   Italy,   Norway,   United Kingdom,   United States
 
NCT00376584
0524A-023, MK0524A-023, 2006_504
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP