Calendario›GILD›Ranolazine
Ranolazine
An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)
Ensayo de GILEAD SCIENCES, INC. en Angina cronica.
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 172
- Centros
- 29
- Fin del objetivo primario
- ene 2011
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2007.
Qué mide
Evaluar la validez del WISQ en mujeres con angina cronica basada en cambios en la frecuencia de angina reportada por el paciente y el consumo de nitroglicerina (NTG) antes y despues del tratamiento con ranolazina evaluados como coeficiente de determinacion (R^2) (del inicio a la semana 4)
Qué se prueba
Se evaluará la validez y fiabilidad del Cuestionario de Síntomas de Isquemia en Mujeres (WISQ) midiendo sus cambios en mujeres con angina tratadas con ranolazina, comparándose con el cuestionario de angina de Seattle ampliamente utilizado.
Lo que dice el documentoevaluate the validity, reliability, and responsiveness of the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ).
Traducción automática (claude-haiku-4-5-20251001). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroAccording to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete or near complete elimination of anginal chest pain and a return to normal activities and functional capacity. However, evaluating angina and responses to antianginal therapy is often not straightforward. This is particularly true of female patients with angina. Because angina and response to antianginal therapy may differ in men and women, an instrument designed specifically to address symptomatology in women with angina could enhance our understanding and characterization of angina and responses to therapy in this population. The current study will evaluate the validity, reliability, and responsiveness of the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ).
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Todos los de GILD, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00644332), actualizada en may 2012.