Calendario›GILD›MBX-8025

MBX-8025

Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol

Ensayo de GILEAD SCIENCES, INC. en Hyperlipidemia (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

183

previstos

Centros

28

Fin del objetivo primario

ago 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en ago 2007.

Qué mide

Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug (8 week treatment period) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in combination with Atorvastatin Total participation for each patient is approximately 16-17 weeks, which may include up to a 2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up. During the run-in period patients taking statins, statin combination or Zetia will undergo a 'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their same diet prior to entering the study). They will be asked to defer initiating any weight loss diets or meaningful changes in their activity level until after they have completed the study. Once randomized into the double blind study, patients will visit the clinic every two weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the double-blind study medication will be discontinued. Patients will attend a follow up visit two weeks after their final dose for safety evaluation.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00701883), actualizada en may 2015.