Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
NCT ID: NCT00653913
Last Updated: 2022-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2004-03-31
2004-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019)
NCT03885921
Efficacy and Safety Study of Ezetimibe (SCH 58235, MK-0653) in Addition to Atorvastatin in Participants With Coronary Heart Disease or Multiple Cardiovascular Risk Factors (P00693/MK-0653-030)
NCT03867318
A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)
NCT00652301
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
NCT06547359
SCH-58235 (Ezetimibe) to Treat Homozygous Sitosterolemia
NCT00045812
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3)
SCH 58235
SCH 58235 10 mg (once daily)
pitavastatin
Pitavastatin 2 mg (once daily)
Group B
SCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3)
SCH 58235
SCH 58235 10 mg (once daily)
pitavastatin
Pitavastatin 2 mg (once daily)
Group C
Pitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3)
SCH 58235
SCH 58235 10 mg (once daily)
pitavastatin
Pitavastatin 2 mg (once daily)
Group D
Pitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3)
SCH 58235
SCH 58235 10 mg (once daily)
pitavastatin
Pitavastatin 2 mg (once daily)
Group E
Coadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3)
SCH 58235
SCH 58235 10 mg (once daily)
pitavastatin
Pitavastatin 2 mg (once daily)
Group F
Coadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3)
SCH 58235
SCH 58235 10 mg (once daily)
pitavastatin
Pitavastatin 2 mg (once daily)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SCH 58235
SCH 58235 10 mg (once daily)
pitavastatin
Pitavastatin 2 mg (once daily)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged 20 years or over and 65 years or below when the informed consent is obtained.
* Weighing 50 kg or over and 80 kg or below on the day of the screening tests, with BMI \[Body Mass Index: body weight (kg)/height (m)2\] ranging from 16.5 to 27.5.
Exclusion Criteria
* Subjects with the triglyceride value at screening test exceeding 500 mg/dL.
* Subjects with past history of drug allergy (shock, anaphylactic symptom, and angioedema).
* Subjects with past history of alcohol or drug dependence.
* Subjects with past history of mental disorder.
* Subjects positive in the test for HBs antigen, HCV antibody, or HIV antibody or in the serological test for syphilis.
* Subjects who used any drug within 2 weeks of investigational product administration in Period 1.
* Subjects who have drawn more than 400 mL of blood within 12 weeks before administration day in Period 1.
* Subjects who participated in other study within 16 weeks of investigational product administration in Period 1 and was administered a investigational product.
* Subjects who cannot take contraceptive measures during the study period (from providing informed consent to completion of Period 3 examination)
* Subjects who the investigator judges are inappropriate to participate in the study.
20 Years
65 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Organon and Co
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P03962
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.