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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00479388
Other study ID # 0524A-067
Secondary ID 2007_521
Status Completed
Phase Phase 3
First received May 24, 2007
Last updated February 20, 2015
Start date July 2007
Est. completion date October 2008

Study information

Verified date February 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.


Recruitment information / eligibility

Status Completed
Enrollment 1216
Est. completion date October 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia

- Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion Criteria:

- Patient whose LDL-C values are not within protocol specified range

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Comparator: simvastatin
simvastatin (20mg to 40mg) for 12 weeks.
niacin (+) laropiprant
One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
Comparator: atorvastatin calcium
atorvastatin calcium (20mg to 40mg) for 12 weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Shah S, Ceska R, Gil-Extremera B, Paolini JF, Giezek H, Vandormael K, Mao A, McCrary Sisk C, Maccubbin D. Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 Baseline and 12 Weeks No
Secondary Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 Baseline and 12 Weeks Yes
Secondary Percent Change From Baseline in Triglycerides at Week 12 Baseline and 12 Weeks No
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