EUCTR2008-001550-41-ESActive, not recruitingPhase 1
Estudio multicéntrico, doble ciego, randomizado, de 12 meses de duración, controlado con placebo, para evaluar el efecto hipolipemiante, la seguridad y la tolerabilidad de AVE5530 25 mg/día y 50mg/día en tratamiento concomitante con estatinas (inhibidores de la HMG-CoA reductasa) en pacientes con hipercolesterolemia primariaA multicenter, double-blind, randomized, 12-month, placebo-controlled study to evaluate the lipid-lowering effect, safety and tolerability of AVE5530 25 mg/day and 50mg/day when added to ongoing stable statin therapy (HMG-CoA reductase inhibitors) in patients with primary hypercholesterolemia.
Sanofi-Aventis Recherche & Développement0 sites1,000 target enrollmentStarted: July 4, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Adult patients:
- •With primary hypercholesterolemia with ongoing statin treatment at the same dose for at least 6 weeks and LDL-C levels = 100 mg/dL (2.59 mmol/L) at screening (considered insufficiently controlled)
- •With informed consent obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Exclusion criteria related to study methodology:
- •Age less than 18 years at screening
- •Administration of other investigational drugs within 30 days or 5 half lives prior to screening visit (Visit 1) (whichever comes the first)
- •Patient who previously participated in another AVE5530 trial
- •Patient who does require immediate dose escalation of statin based on investigator’s judgment
- •LDL-C levels > 250 mg/dL (6.48 mmol/L)
- •Triglycerides >350 mg/dL (3.95 mmol/L)
- •Conditions / situations such as:
- •- Patients with conditions/concomitant diseases
- •Making them non-evaluable for the primary efficacy endpoint: such as presence of any clinically significant not controlled endocrine disease known to influence serum lipids or lipoproteins. Patients on thyroid replacement therapy can be included if the dosage of thyroxine has been stable for at least 3 months prior to screening and their s-TSH sensitive TSH) levels is within ±10% of the normal ranges of the Central Laboratory.
- •Any conditions considered to be medically sound by the investigator that would limit the patient’s safe participation in the study such as: Active liver disease, as shown by but not limited to alanine aminotransferase (ALT) or aspartate amino-transferase (AST) > 3xUpper Limit Normal (ULN) range, Neutrophils < 1,500/mm3, Platelets counts < 100 000/ mm3, Unexplained CPK > 3xULN, CHD or CHD risk equivalents (10-year risk >20% based on Framingham risk score), Recent history (within 3 months of study screening and through to randomization) of moderate or severe congestive heart failure [New York Heart Association (NYHA) Class III or IV], Recent history of unstable angina pectoris, myocardial infarction, coronary bypass
- •surgery or angioplasty within 3 months of study screening, Unstable or severe peripheral artery disease within 3 months of study screening and through to randomization, Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody, Known to be Human Immunodeficiency Virus (HIV) positive
- •- Presence of any other conditions (e.g. geographic, social….) actual or anticipated that the investigator feels would restrict or limit the patient’s participation for the duration of the study
- •- Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- •- Administration of any lipid-lowering treatment other than the ongoing statin in the preceding 6 weeks or after the screening visit.
- •Exclusion criteria related to AVE5530 compound:
- •Pregnant or breast-feeding women,
- •Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product .
Investigators
Similar Trials
Active, not recruiting
Phase 1
Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.Artritis ReumatoideRheumatoid ArthritisMedDRA version: 12.0Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2009-012759-12-ESF. Hoffmann-La Roche Ltd.1,128
Active, not recruiting
Phase 1
Estudio multicéntrico, randomizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de bevacizumab en combinación con docetaxel, en comparación con docetaxel más placebo, como tratamiento en primera línea de pacientes con cáncer de mama metastático HER2 negativo. - AVADOEUCTR2005-003862-40-ESF. Hoffmann-La Roche Limited736
Active, not recruiting
Not Applicable
Estudio multicéntrico, randomizado, doble ciego, con doble enmascaramiento, controlado frente a un comparador activo para evaluar la eficacia, seguridad y tolerancia de taspoglutida (RO5073031) comparado con pioglitazona en pacientes con diabetes mellitus tipo 2 controlados inadecuadamente con sulfonilurea (SU) en monoterapia o con la combinación metformina más sulfonilurea. A multicenter, randomized, double blind (double dummy), active-comparator controlled study to compare the efficacy, safety and tolerability of taspoglutide versus pioglitazone in type 2 diabetes patients inadequately controlled with sulfonylurea (SU) monotherapy or metformin plus sulfonylurea combination therapy. - EMERGE 6Pacientes con diabetes mellitus tipo 2Patients with Type 2 diabetesMedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitusMedDRA version: 9Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)EUCTR2009-009157-24-ESF. Hoffmann-La Roche Ltd648
Active, not recruiting
Phase 1
Estudio multicéntrico, randomizado, doble ciego, controlado con placebo, con grupos de tratamiento paralelos, de dos años de duración, para evaluar el efecto de RO4909832 administrado por vía subcutánea sobre la capacidad cognitiva y funcional en enfermedad de Alzheimer en fase prodrómica.Enfermedad de Alzheimer en fase prodrómicaProdromal Alzheimer's DiseaseMedDRA version: 12.1Level: LLTClassification code 10066571Term: Progression of Alzheimer's diseaseEUCTR2010-019895-66-ESF. Hoffmann-La Roche Ltd797
Active, not recruiting
Not Applicable
Estudio de Tamiflu vs placebo en el tratamiento profiláctico de la gripe en pacientes inmunocomprometidosProfilaxis estacional de la gripe en pacientes inmunocomprometidosMedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2006-002473-47-ESF.Hoffmann-La Roche Ltd.470