Primary Hypercholesterolemia Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.
| Verified date | February 2015 |
| Source | Merck Sharp & Dohme Corp. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.
| Status | Completed |
| Enrollment | 1216 |
| Est. completion date | October 2008 |
| Est. primary completion date | July 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia - Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria Exclusion Criteria: - Patient whose LDL-C values are not within protocol specified range |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme Corp. |
Shah S, Ceska R, Gil-Extremera B, Paolini JF, Giezek H, Vandormael K, Mao A, McCrary Sisk C, Maccubbin D. Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 | Baseline and 12 Weeks | No | |
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 | Baseline and 12 Weeks | Yes | |
| Secondary | Percent Change From Baseline in Triglycerides at Week 12 | Baseline and 12 Weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05559606 -
An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe
|
||
| Completed |
NCT03571087 -
Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT00776321 -
Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
|
Phase 2 | |
| Recruiting |
NCT05399992 -
Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD
|
||
| Withdrawn |
NCT05798390 -
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
|
||
| Completed |
NCT06448962 -
Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022
|
Phase 3 | |
| Completed |
NCT00724477 -
Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)
|
||
| Completed |
NCT00249249 -
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
|
Phase 3 | |
| Recruiting |
NCT05657574 -
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT03516955 -
Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting
|
||
| Completed |
NCT02941848 -
Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01012219 -
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
|
Phase 1 | |
| Completed |
NCT05131997 -
A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A
|
Phase 3 | |
| Terminated |
NCT03433755 -
Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
|
Phase 3 | |
| Completed |
NCT00867165 -
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
|
Phase 3 | |
| Not yet recruiting |
NCT06386419 -
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
|
Phase 4 | |
| Active, not recruiting |
NCT03952169 -
Effect of Probiotics on Lipid Management
|
N/A | |
| Terminated |
NCT01335997 -
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
|
Phase 3 | |
| Completed |
NCT02087917 -
A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
|
Phase 2 | |
| Completed |
NCT00704535 -
Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
|