Estudio Aleatorizado y Doble Ciego de 52 Semanas para Eva... | EligiMed

Estudio Aleatorizado y Doble Ciego de 52 Semanas para Evaluar la Seguridad y Eficacia de un Régimen con LCZ696 Comparado con un Régimen con Olmesartan sobre la Rigidez Arterial mediante la Evaluación de la Presión Arterial Central en Pacientes Ancianos con Hipertensión

CompletadoFase 2ClinicalTrials.gov

ID: NCT01692301Tipo: INTERVENTIONALInicio: 1 de dic de 2012Fin estimado: 1 de abr de 2015

Resumen

El estudio examinó la eficacia de LCZ696 en comparación con el ARA II olmesartan sobre la Presión Arterial Sistólica Aórtica Central (PASAC) y otras medidas de hemodinámica central y rigidez arterial en pacientes ancianos con presión arterial sistólica (PAS) elevada y presión de pulso (PP) ampliada.

Elegibilidad

Edad mínima: 60 YearsSexo: ALL

Criterios de inclusión

Male and female patients ≥ 60 years of age.
Patients with essential hypertension, untreated or currently taking antihypertensive therapy.
Untreated patients must have an office msSBP ≥150 mmHg and \<180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
Treated patients must have an office msSBP ≥140 mmHg and \<180 mmHg at Visit 102 (or Visit 103) and msSBP ≥150 mmHg and \<180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
All patients must have pulse pressure \>60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.
Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201.

Criterios de exclusión

Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
History of angioedema, drug-related or otherwise.
History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening.

Intervenciones

drug

LCZ696

200 mg tablet

drug

Olmesartan

20 mg and 40 mg capsules

drug

LCZ696 matching placebo

LCZ696 Matching Placebo tablet

drug

Olmesartan matching placebo

Olmesartan matching placebo capsule

drug

amlodipine

amlodipine 2.5 mg or 5 mg tablets

drug

hydrochlorothiazide

hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets

Ubicaciones

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Ramos Mejía, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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