Benefit of Elevation of HDL-C in Women

NCT01921010 | Completed Phase 4

• 1 other identifier: 3954
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction accomplished by the addition of niacin to statin medication would improve endothelial function as compared to LDL-C reduction alone in patients with and without coronary artery disease and the combination of low HDL-C/high triglycerides. The combination of lipid lowering therapy would have beneficial effects on markers of inflammation. These benefits would be particularly evident in women.

Conditions

Cardiovascular Outcomes

Outcome Measures

Primary Outcomes (1)

• endothelial function

  16 weeks

Study Arms (2)

Niaspan

ACTIVE COMPARATOR

Patients will be randomized to Niaspan 1.5 g/d in addition to usual care statin lipid lowering agents. The dose of Niaspan will be titrated over a 4-week period and then patients will remain on study drug for additional 12 weeks. The dose of statin will be adjusted in a blinded fashion in both groups at week 10 to similarly achieve a LDL-C of less than 100mg/dl.

Drug: Niaspan

Control

PLACEBO COMPARATOR

patients will be randomized to placebo 1.5 g/d in addition to usual care statin lipid lowering agents. The dose of placebo will be titrated over a 4-week period and then patients will remain on study drug for additional 12 weeks. The dose of statin will be adjusted in a blinded fashion in both groups at week 10 to similarly achieve a LDL-C of less than 100mg/dl.

Drug: Placebo

Interventions

Niaspan DRUG

See Arm Description

Niaspan

Placebo DRUG

See Arm Description

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable CAD(coronary artery disease) patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
• Well-controlled diabetes with HbA1C \< 7.5 currently on statin therapy, able to tolerate Niacin without unstable blood glucose levels with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
• Stable patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl

You may not qualify if:

• History of MI(myocardial infarction), PTCA(percutaneous transluminal coronary angiography) or surgery within previous 3 months
• Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin
• Active or known gall bladder disease
• Pregnant or nursing women
• Significant comorbidity that precludes participation
• Significant liver disease, active alcoholism, or LFT(liver function test) \>1.5x's ULN( upper limit of normal) at screening
• Diabetes with Hg A1C(hemoglobin A1c) \< 7.5
• PI perceived inability to comply with protocol

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Niacin

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• C. Noel Bairey Merz, M.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 13, 2013
• Study Start: June 1, 2003
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)