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Sitosterolemia Extension Study (0653-003)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092807
First received: September 23, 2004
Last updated: May 10, 2017
Last verified: May 2017
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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: | 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 - 1 Year Open-Label Extension |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
Secondary Outcome Measures:
- Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK0653 10 mg/day in patients with homozygous sitosterolemia
| Enrollment: | 37 |
| Actual Study Start Date: | February 12, 2001 |
| Study Completion Date: | November 30, 2004 |
| Primary Completion Date: | September 18, 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) |
| Sexes Eligible for Study: | All |
| 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
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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: NCT00092807
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092807
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications:
Study Data/Documents: CSR Synopsis
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00092807 History of Changes |
| Other Study ID Numbers: |
P02257 2004_032 |
| Study First Received: | September 23, 2004 |
| Last Updated: | May 10, 2017 |
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 July 24, 2017