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Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664287
First Posted: April 22, 2008
Last Update Posted: April 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.

Condition Intervention Phase
Dyslipidemia Drug: niacin (+) laropiprant Drug: placebo (unspecified) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Dyslipidemic Patients Deemed Appropriate for Further Lipid Modification.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks. [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks. [ Time Frame: 3 months ]

Enrollment: 0
Study Start Date: September 2008
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Patients will remain on existing lipid-modifying therapy throughout the study. Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.
Drug: niacin (+) laropiprant
Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.
Other Name: MK0524A
Placebo Comparator: Group 2
Patients will remain on existing lipid-modifying therapy throughout the study. Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.
Drug: placebo (unspecified)
Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older and on a stable dose of lipid therapy

Exclusion Criteria:

  • Patients lipid level is outside the recommended range
  • Patients that are HIV positive
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664287


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00664287     History of Changes
Other Study ID Numbers: 0524A-082
2008_504
First Submitted: April 21, 2008
First Posted: April 22, 2008
Last Update Posted: April 9, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs