Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01012219
Other study ID # 0524A-114
Secondary ID 2009_689
Status Completed
Phase Phase 1
First received November 10, 2009
Last updated October 30, 2015
Start date November 2009
Est. completion date April 2010

Study information

Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date April 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Participant has primary hypercholesterolemia or mixed dyslipidemia (high cholesterol)

- Participant is a non-smoker

Exclusion Criteria:

- Participant has a history of chronic seizures

- Participant has a history of cancer

- Participant has a history of stomach or intestinal ulcers or any history of GI bleeding

- Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
niacin (+) laropiprant
open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets
Comparator: aspirin
81 mg oral tablet once daily for 7 days
Comparator: clopidogrel
75 mg oral tablet once daily for 7 days
Comparator: laropiprant
40 mg oral tablet once daily for 7 days
Comparator: placebo
placebo oral tablet once daily for 7 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

De Kam PJ, Luo WL, Wenning L, Ratcliffe L, Sisk CM, Royalty J, Radziszewski W, Wagner JA, Lai E. The effects of laropiprant on the antiplatelet activity of co-administered clopidogrel and aspirin. Platelets. 2014;25(7):480-7. doi: 10.3109/09537104.2013.83 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cutaneous Bleeding Time (BT) Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days.
The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable.
Period 3 was not analyzed as bleeding time was not an objective for this part of the study.
Day 8 No
See also
  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 NCT02941848 - Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers Phase 1
Completed NCT03516955 - Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting
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)
Recruiting NCT06314919 - A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib