Merck Carotid Atherosclerosis Trial - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00804843

Purpose

This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers

Condition	Intervention	Phase
Carotid Atherosclerosis	Drug: Atorvastatin/niacin extended-release Drug: Atorvastatin Drug: Simvastatin	Phase II

MedlinePlus related topics: Statins

Drug Information available for: Niacin Simvastatin Niacinamide Atorvastatin Atorvastatin calcium Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Clinical Trial to Evaluate the Effects of High Dose Statin and Niacin Therapy on Excised Plaque Biomarkers in Patients Undergoing Carotid Endarterectomy (CEA)

Further study details as provided by Merck:

Primary Outcome Measures:

Comparison of plaque stability biomarkers and cholesterol levels following treatment [ Time Frame: 4 to 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental statin/niacin extended-release	Drug: Atorvastatin/niacin extended-release 80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks. Drug: Simvastatin (Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
B: Active Comparator statin	Drug: Atorvastatin 10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks. Drug: Simvastatin (Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

Arms

Assigned Interventions

A: Experimental

statin/niacin extended-release

Drug: Atorvastatin/niacin extended-release

80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

Drug: Simvastatin

(Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

B: Active Comparator

statin

Drug: Atorvastatin

10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

Drug: Simvastatin

(Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is diagnosed with carotid stenosis AND is scheduled to undergo carotid endarterectomy
Female patients of reproductive potential must abstain from sex or use an acceptable method of birth control through out the study

Exclusion Criteria:

Patient must undergo CEA less than 4 weeks after entering study
Patient has recent history of acute coronary syndrome
Patient has has coronary artery bypass graft surgery within 30 days of study start
Patient has thyroid disease that has not been treated for more than 6 weeks
Patient has donated blood within 8 weeks of study start
Patient has poorly controlled diabetes mellitis
Patient has HIV or Hepatitis B or C
Patient is taking warfarin or other anticoagulants
Patient is taking hormone replacement therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804843

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Florida
Call for Information	Recruiting
Pensacola, Florida, United States, 32504
United States, Pennsylvania
Call for Information	Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Italy
Merck Sharp & Dohme (Italia) S.P.A.	Recruiting
Roma, Italy, 191
Contact: Gianfranco Botta 39 06 36 191187
Spain
Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
Madrid, Spain, 28027
Contact: Jorge Gonzalez-Esteban 34-91-3210-728

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_598, 111
Study First Received:	December 8, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00804843 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Vasodilator Agents
Vitamin B Complex
Niacinamide
Simvastatin
Antilipemic Agents
Vascular Diseases
Central Nervous System Diseases
Trace Elements
Anticholesteremic Agents

Cardiovascular Agents
Arteriosclerosis
Brain Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cerebrovascular Disorders
Nicotinic Acids
Vitamins
Micronutrients
Carotid Artery Diseases
Niacin
Atorvastatin

Additional relevant MeSH terms:

Atherosclerosis
Antimetabolites
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Therapeutic Uses
Vitamins
Cardiovascular Diseases
Micronutrients
Arterial Occlusive Diseases
Vitamin B Complex

Simvastatin
Antilipemic Agents
Growth Substances
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Carotid Artery Diseases
Niacin
Atorvastatin

ClinicalTrials.gov processed this record on May 07, 2009