Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED) (ACHIEVE)
|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.|
|ClinicalTrials.gov Identifier: NCT00384293|
Recruitment Status : Terminated
First Posted : October 6, 2006
Results First Posted : September 2, 2009
Last Update Posted : September 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia, Familial||Drug: Comparator: niacin (+) laropiprant (MK0524A) Drug: Comparator: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||937 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Drug: Comparator: niacin (+) laropiprant (MK0524A)
niacin (+) laropiprant (2 g) po qd.
Other Name: MK0524A
Placebo Comparator: 2
Drug: Comparator: placebo
niacin (+) laropiprant (2 g) placebo po qd.
- Change in Mean Carotid Intima Media Thickness [ Time Frame: after 96 weeks of postrandomization treatment ]change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.
- Change in Lipid Profile [ Time Frame: after 96 weeks of postrandomization treatment ]
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): NCT00384293
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|