SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia

NCT00194402 | Completed Phase 4

• 1 other identifier: 03-6262-A
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.

Conditions

Dyslipidemia

Keywords

cholesterol; dyslipidemia; hypercholesterolemia; C-reactive protein

Outcome Measures

Primary Outcomes (1)

• LDL-C change for atorvastatin 10 mg, Slo-Niacin 1500 mg, and the two together.

  Change from baseline to 12 weeks and end of intervention

Secondary Outcomes (1)

• Change in HDL-C, HDL2-C, HDL3-C, LDL-C:HDL-C, triglyceride, remnant lipoprotein, apoproteins A-I and B, LDL buoyancy, hsCRP, glucose, insulin, and SGOT.

  Change from baseline to end of 12 weeks and/or end of intervention

Study Arms (2)

1

ACTIVE COMPARATOR

Atorvastatin 10 mg for 12 weeks followed by Slo-Niacin (titrated from 500 to 1500 mg over 8 weeks) taken with atorvastatin 10 mg for an additional 12 weeks

Drug: Slo-Niacin, atorvastatin

2

ACTIVE COMPARATOR

Slo-Niacin (titrated from 500 to 1500 mg over 8 weeks) for 12 weeks followed by atorvastatin 10 mg taken with Slo-Niacin 1500 mg for an additional 12 weeks

Drug: Slo-Niacin, atorvastatin

Interventions

Slo-Niacin, atorvastatin DRUG

Atorvastatin 10 mg qd for 12 or 24 weeks. Time-released niacin 1500 mg qd (titrated from 500mg to 1000mg and then to 1500 mg at 4 week intervals) taken for 12 or 24 weeks.

Also known as: Lipitor (R) (Atorvastatin), Slo-Niacin (R) (time-release niacin

1; 2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL-C \> 130 mg/dL
• HDL-C \<= 45 mg/dL in men and \<= 55 mg/dL in women

You may not qualify if:

• history of hypersensitivity to any statin, niacin or aspirin
• diagnosis of diabetes or a fasting glucose \> 125 mg/dL
• hyper or hypothyroidism (unless treatment stable)
• meet other health, medication, and logistical criteria

Sponsors & Collaborators

• University of Washington: lead
• Upsher-Smith Laboratories: collaborator

Study Sites (1)

Northwest Lipid Research Clinic, University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia

Interventions

Niacin; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Robert H. Knopp, MD

  Northwest Lipid Research Clinic, University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: August 21, 2008

Record last verified: 2008-08

Locations

US (1)