WHO ICTRP trial
"Estudio aleatorizado, doble ciego, con control activo, multicéntrico en…
EUCTR2008-005002-40-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2008-005002-40-ES |
|---|---|
| Public title | "Estudio aleatorizado, doble ciego, con control activo, multicéntrico en pacientes con hipercolesterolemia primaria y alto riesgo cardiovascular y no controlados adecuadamente con Atorvastatina 20 mg: una comparación entre el cambio a un comprimido combinado de Ezetimiba/Simvastatina (10mg/40mg) frente a la duplicación de la dosis basal de Atorvastatina a 40 mg" A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk and not Adequately Controlled with Atorvastatin 20 mg: A Comparison of Switching to a Combination TabletEzetimibe/Simvastatin (10mg/40mg) versus Doubling the Baseline Dose to Atorvastatin 40 mg |
| Scientific title | "Estudio aleatorizado, doble ciego, con control activo, multicéntrico en pacientes con hipercolesterolemia primaria y alto riesgo cardiovascular y no controlados adecuadamente con Atorvastatina 20 mg: una comparación entre el cambio a un comprimido combinado de Ezetimiba/Simvastatina (10mg/40mg)… |
| Primary sponsor | Merck & Co., Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;Estonia;Hungary;Spain;Latvia |
| Conditions | hipercolesterolemia primaria primary hypercholesterolemia MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia |
| Interventions | Trade Name: VYTORIN 10 mg/40 mg comprimidos Pharmaceutical Form: Tablet INN or Proposed INN: EZETIMIBA Other descriptive name: EZETIMIBE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- INN or Proposed… |
| Registration date | Sep 17, 2008 |
| Target size | 240 |
| Secondary IDs | 0653A-134 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: