Vytorin Reexamination Study (0653A-174)
NCT01070966 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2089
Last updated 2022-02-09
Summary
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Conditions
- Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Sponsors & Collaborators
-
Organon and Co
lead INDUSTRY
Eligibility
- Min Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-07-31
- Primary Completion
- 2010-04-30
- Completion
- 2010-04-30
More Related Trials
-
Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers
NCT02393950 ·Status: COMPLETED ·Phase: PHASE1
-
Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers
NCT01784536 ·Status: COMPLETED ·Phase: PHASE1
-
Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
NCT01470326 ·Status: COMPLETED
-
Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH)
NCT06458010 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706
NCT03235362 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
NCT02170220 ·Status: COMPLETED ·Phase: PHASE1
-
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
NCT04810533 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356
NCT04147910 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How BI 1291583 is Processed in the Body
NCT05833035 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers
NCT03866928 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants
NCT07250633 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Absorption, Metabolism, Excretion and Absolute Bioavailability
NCT03250039 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
NCT01359605 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral Dose
NCT06886269 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B"
NCT06184269 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body
NCT03654170 ·Status: COMPLETED ·Phase: PHASE1
-
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects
NCT04415645 ·Status: COMPLETED ·Phase: PHASE1
-
Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers
NCT04246749 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
NCT06309394 ·Status: COMPLETED ·Phase: PHASE1
-
STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study
NCT01181505 ·Status: COMPLETED ·Phase: PHASE1
-
Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects
NCT02418650 ·Status: COMPLETED ·Phase: PHASE1
-
Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects
NCT05238714 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH)
NCT06461702 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers
NCT01592890 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers
NCT02597998 ·Status: COMPLETED ·Phase: PHASE1