A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL, PLACEBO-CONTROLLED 12-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EXTENDED RELEASE (ER) NIACIN/LAROPIPRANT WHEN ADDED TO ONGOING LIPID-MODIFYING THERAPY IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA

Not Applicable

• Registration Number: PER-056-11
• Lead Sponsor: MERCK & CO.INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

PROTOCOL-SPECIFIC:
1. PATIENT HAS A HISTORY OF PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA.
NOTE: AS DETERMINED BY MEDICAL HISTORY, HISTORICAL AND/OR CURRENT LAB VALUES, AND INVESTIGATOR´S JUDGMENT.
2. PATIENT MUST MEET ONE THE FOLLOWING RISK CATEGORIES AND CORRESPONDING LDL-C CRITERIA (DETAILED DEFINITIONS OF RISK CATEGORIES ARE IN APPENDIX 6.1) AT VISIT 2.
3. PATIENT HAS TG LEVELS < 500 mg/dL (< 5.65 mmol/L).
NOTE: PLEASE SEE TABLE 3-1 FOR RETEST GUIDANCE FOR TG AND LDL-C.
4. PATIENT HAS BEEN ON A STABLE DOSE OF ONE OF THE FOLLOWING LMTs FOR AT LEAST 6 WEEKS PRIOR TO VISIT 1, AND AGREES TO REMAIN ON THE SAME TYPE AND DOSE OF LMT FOR THE DURATION OF THE STUDY:
• MONOTHERAPY: SIMVASTATIN OR ROSUVASTATIN OR ATORVASTATIN
• COMBINATION THERAPY: EZETIMIBE/SIMVASTATIN IN THE SAME TABLET
• COADMINISTRATION THERAPY: SIMVASTATIN OR ROSUVASTATIN OR ATORVASTATIN COADMINISTERED WITH EZETIMIBE
NOTE: PRODUCT CIRCULARS SHOULD BE FOLLOWED FOR EACH LMT.
GENERAL:
5. PATIENT IS MALE OR FEMALE AND ≥ 18 YEARS OF AGE ON DAY OF SIGNING INFORMED CONSENT. 

Exclusion Criteria

PROTOCOL-SPECIFIC:
1. PATIENT HAS TAKEN A PROHIBITED LMT WITHIN 6 WEEKS OF VISIT 1. EXAMPLES OF PROHIBITED LMT INCLUDE PRAVASTATIN, LOVASTATIN, FLUVASTATIN, BILE ACID SEQUESTRANTS, FIBRALES (MONOTHERAPY, CO-ADMINISTRATION OR COMBINATION WITH OTHER LMT), NIACIN > 50 mg AND RED YEAST RICE PRODUCTS.
2. PATIENT HAS HAD A CHANGE TO THE TYPE OR DOSE OF ACCEPTABLE LMT REGIMEN WITHIN 6 WEEK OF VISIT 1.
3. PATIENT IS PREGNANT, BREASTFEEDING, OR EXPECTING TO CONCIEVE DURING THE STUDY INCLUDING THE 14-DAY POSTSTUDY FOLLOW-UP.
4. PATIENT HAS A HISTORY OF MALIGNANCY ≤ 5 YEARS PRIOR TO SIGNING INFORMED CONSENT, EXCEPT FOR ADEQUATELY TREATED BASAL CELL OR SQUAMOUS CELL SKIN CANCER OR IN SITU CERVICAL CANCER.
5. FEMALE PATIENT IS EXPECTING TO DONATE EGGS DURING THE STUDY, INCLUDING THE 14-DAY FOLLOW-UP.
6. PATIENT IS UNLIKELY TO ADHERE TO THE STUDY PROCEDURES KEEP APPOINTMENT OR IS PLANNING TO RELOCATE DURING THE STUDY.
7. PATIENT HAS PARTICIPATED IN A STUDY, INCLUIDING POST-STUDY FOLLOW-UP WITH AN INVESTIGATIONAL COMPOUND (NON-LIPID-MODIFYING) WITHIN 30 DAYS OF VISIT 1 OR A LIPID-MODIFYING COMPOUND (INVESTIGATIONAL OR MARKETED), WITHIN 6 WEEKS OF VISIT 1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified