Trial record 11 of 13 for:    "sitosterolemia" OR "beta-sitosterolemia" OR "phytosterolaemia" OR "sitosterolaemia" OR "Mediterranean stomatocytosis macrothrombocytopenia"

A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704444
First received: June 23, 2008
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 12-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Condition Intervention
Hypercholesterolemia
Familial Hypercholesterolemia
Homozygous Sitosterolemia
Drug: Ezetimibe
Drug: Ezetimibe + other lipid-lowering medication(s)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Adverse events will be monitored throughout the 12-week period. (Subjects who discontinue Zetia treatment during the 12-week period will be investigated up to the time of therapy discontinuation ) ] [ Designated as safety issue: Yes ]
  • Change in LDL-C [ Time Frame: LDL-C at start of 12 weeks will be compared to LDL-C at the end of the 12-week period. ] [ Designated as safety issue: Yes ]

Enrollment: 11332
Study Start Date: June 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Zetia monotherapy
Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia
Drug: Ezetimibe
Ezetimibe, 10-mg tablets
Other Name: Zetia
Zetia combination therapy
Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia
Drug: Ezetimibe + other lipid-lowering medication(s)
Ezetimibe, 10-mg tablets + other lipid-lowering medication(s), as prescribed by attending physician
Other Name: Zetia + other lipid-lowering medication(s)

Detailed Description:

The population will be selected from 2,000 institutions in Japan.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The population will be selected from 2,000 institutions in Japan.

Criteria

Inclusion Criteria:

  • Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study.

Zetia monotherapy patients must be treated with Zetia alone.

Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia.

Exclusion Criteria:

  • Patients with a history of hypersensitivity to any ingredient in Zetia
  • Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704444     History of Changes
Other Study ID Numbers: P05244
Study First Received: June 23, 2008
Last Updated: March 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Intestinal Diseases
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Gastrointestinal Diseases
Digestive System Diseases
Hypolipidemic Agents
Ezetimibe
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents

ClinicalTrials.gov processed this record on August 27, 2014