Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |
---|---|
First Received Date ICMJE | September 23, 2004 |
Last Updated Date | May 17, 2006 |
Start Date ICMJE | March 2001 |
Current Primary Outcome Measures ICMJE |
To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK-0653 10 mg/day. |
Original Primary Outcome Measures ICMJE |
Plasma sitosterol levels after 52 weeks |
Change History | Complete list of historical versions of study NCT00092807 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK-0653 10 mg/day in patients with homozygous sitosterolemia |
Original Secondary Outcome Measures ICMJE |
Plasma LDL-C and plasma campesterol. Safety and tolerability |
Descriptive Information | |
Brief Title ICMJE | Sitosterolemia Extension Study |
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK-0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label Extension |
Brief Summary | 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. |
Detailed Description | The duration of treatment is 52 weeks. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Safety Study |
Condition ICMJE |
|
Intervention ICMJE |
|
Study Arms / Comparison Groups | |
Publications * | Salen G, von Bergmann K, Lutjohann D, Kwiterovich P, Kane J, Patel SB, Musliner T, Stein P, Musser B; Multicenter Sitosterolemia Study Group. Ezetimibe effectively reduces plasma plant sterols in patients with sitosterolemia. Circulation. 2004 Mar 2;109(8):966-71. Epub 2004 Feb 09. |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|
Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 14 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
Gender | Both |
Ages | 10 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID ICMJE | NCT00092807 |
Responsible Party | |
Study ID Numbers ICMJE | 2004_032 |
Study Sponsor ICMJE | Merck |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Merck |
Verification Date | October 2005 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |