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NCT00461968
Genetic Determinanats of Cardiovascular Risk Factors: Comparison of Efficacy and Safety of Ezetimibe or Statin Monotherapy to Co-Administration of Both
NA trial testing Ezetimibe and Simvastatin in Cholesterol, LDL in 240 participants. Completed in 1 April 2007.
Quick facts
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 1 February 2005 |
| Estimated completion | 1 April 2007 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ezetimibe and Simvastatin — full drug profile →
Conditions studied
- Cholesterol, LDL — all drugs for Cholesterol, LDL →
Sponsor
University of Texas Southwestern Medical Center
Who can join
Adults 20 to 70, male only, with Cholesterol, LDL. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- The primary endpoints of the study will be the percent change in plasma LDL-C concentrations in response to each agent.
- The treatment effect for each individual will be the percent reduction achieved with each agent.
Sponsor's own description
The purpose of this study is to compare the percent change in LDL cholesterol induced by ezetimibe or simvastatin monotherapy and by co-administration of both agents in Black, White and Hispanic men. Ezetimibe is a drug that blocks sterol absorption and simvastatin blocks hepatic cholesterol biosynthesis. The hypothesis to be tested is that Blacks are likely to be more responsive to LDL lowering by ezetimibe than statins because Blacks have a low production of cholesterol.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00461968
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Texas Southwestern Medical Center trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00461968 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
- Last refreshed: 17 April 2007
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00461968.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing