Recruitment

Recruitment Status
Completed

Inclusion Criterias

Stable CAD(coronary artery disease) patients on statin therapy 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
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 CAD(coronary artery disease) patients on statin therapy 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
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

Exclusion Criterias

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

Summary

Conditions
Cardiovascular Outcomes
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 100 years
Gender
Only females

Inclusion Criterias

Stable CAD(coronary artery disease) patients on statin therapy 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
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 CAD(coronary artery disease) patients on statin therapy 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
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

Exclusion Criterias

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

Locations

Los Angeles, California, 90048
Los Angeles, California, 90048

Tracking Information

NCT #
NCT01921010
Collaborators
Not Provided
Investigators
  • Principal Investigator: C. Noel Bairey Merz, M.D. Cedars-Sinai Medical Center
  • C. Noel Bairey Merz, M.D. Cedars-Sinai Medical Center