Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) Clinical Trial
Official title:
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of VYTORIN in Usual Practice
| NCT number | NCT01070966 |
| Other study ID # | 0653A-174 |
| Secondary ID | 2010_010 |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2005 |
| Est. completion date | April 2010 |
| Verified date | February 2022 |
| Source | Organon and Co |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 2089 |
| Est. completion date | April 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years and older |
| Eligibility | Inclusion Criteria: - Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Organon and Co |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation | Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment. | Up to 14 days after the treatment discontinuation | |
| Primary | Mean Percent Change From Baseline to Treatment in Lipid Parameters | The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years. | Baseline and up to 5 years |