We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 552 for:    "chanarin-dorfman syndrome" OR "lipid metabolism, inborn errors"

Sitosterolemia Extension Study (0653-004)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092820
First Posted: September 28, 2004
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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
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)
Detailed Description:
The duration of treatment is 52 weeks.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092820


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092820     History of Changes
Other Study ID Numbers: P02243
2004_033
First Submitted: September 23, 2004
First Posted: September 28, 2004
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Homozygous Sitosterolemia

Additional relevant MeSH terms:
Lipid Metabolism, Inborn Errors
Heart Diseases
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