Sitosterolemia Extension Study (0653-004)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092820
First received: September 23, 2004
Last updated: February 16, 2015
Last verified: February 2015
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Purpose
This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Lipid Metabolism, Inborn Errors Heart Disease |
Drug: MK0653, ezetimibe Drug: Comparator: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
sitosterolemia
MedlinePlus related topics:
Lipid Metabolism Disorders
Drug Information available for:
Ezetimibe
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Plasma sitosterol levels after 52 weeks.
Secondary Outcome Measures:
- Plasma LDL-C and plasma campesterol. Safety and tolerability.
| Enrollment: | 58 |
| Study Start Date: | February 2001 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | September 2001 (Final data collection date for primary outcome measure) |
The duration of treatment is 52 weeks.
Eligibility| Ages Eligible for Study: | 10 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with elevated sitosterol levels while taking current medication
Exclusion Criteria:
- Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092820
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092820
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications:
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00092820 History of Changes |
| Other Study ID Numbers: | P02243 2004_033 |
| Study First Received: | September 23, 2004 |
| Last Updated: | February 16, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck Sharp & Dohme Corp.:
|
Homozygous Sitosterolemia |
Additional relevant MeSH terms:
|
Heart Diseases Metabolism, Inborn Errors Lipid Metabolism, Inborn Errors Cardiovascular Diseases Genetic Diseases, Inborn Metabolic Diseases Lipid Metabolism Disorders |
Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on September 23, 2016