Hipertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: Rasilez
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Rasilez
Pharmaceutical
Sponsors
Novartis Farmaceutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female outpatients 18 years of age and older. - Patients with a diagnosis of uncomplicated essential hypertension; newly diagnosed or who have not received antihypertensive medication within 4 weeks of Visit 1 must have an office cuff msDBP = 100 mmHg and = 110 mmHg at Visit 1. - Patients receiving antihypertensive treatment must have a cuff msDBP of = 95 mmHg and = 110 mmHg at Visit 1. - Prior to the randomization, all patients must have an office cuff msDBP = 100 mmHg and = 110 mmHg. 4. Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). 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: For full list, see protocol Patients with any of the following at Visit 1 or 2 at which the patient will be excluded from participation in the study. 1. Previously treated with aliskiren in the last six months or have previously participated in an aliskiren trial in this development program within the last six months and who qualified to be randomized or enrolled into the active drug treatment period. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (= 5 mIU/ml). 3. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, and oral), and double-barrier methods (if accepted by local ethics committee). Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. 4. Patients with an office cuff blood pressure of msDBP = 112 mmHg and/or msSBP = 200 mmHg 5. History or evidence of a secondary form of hypertension. 6. Previous or current diagnosis of heart failure (NYHA Class II, III and IV). 7. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 8. Serum potassium = 5.3 mEq/L (mmol/L) at Visit 1. 9. Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled as determined by local country criteria. It is recommended that patients currently being treated for diabetes mellitus be on a stable dose of antidiabetic medication for at least 4 weeks prior to Visit 1. 10. Current angina pectoris requiring pharmacological therapy (the use of nitrates for the treatment of angina will be allowed). 11. Second or third degree heart block without a pacemaker. 12. Potentially life threatening arrhythmia during the 12 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparar la eficacia de 300 mg de aliskiren una vez al día con 150 mg de aliskiren dos veces al día para reducir la media de presión arterial diastólica ambulatoria (MPADA) durante 24 horas, desde la situación basal al final del período 2 del estudio (semana 6) en pacientes con hipertensión esencial.;Secondary Objective: Evaluar la eficacia de: 300mg de SPP100 1vez/día vs 150mg 2veces/día para reducir MPADA y MPASA las 3últimas horas del período de dosis de 24h. De 300mg de SPP100 1vez/día vs 150mg 2 veces/día para reducir MPAS durante 24h. De en términos de la reducción de la MPADA durante 24h. y de la MPASA,de 300mg de SPP100 1vez/ día desde el final del período2 hasta fin de estudio, en los pacientes tratados con 150mg de SPP100 dos veces/día durante el período2. De en términos de reducción de la MPADA durante 24h y de la MPASA, de 300mg de SPP100 1vez/día desde el final del período2 hasta el fin del estudio, en los pacientes con 300mg de SPP100 1vez/día durante el período2.De en términos de la reducción de mPADs y la mPASs, de 300mg de SPP100 1vez/día vs 150mg de SPP100 2 veces/día.La proporción de pacientes que llega al objetivo de control de PA.La proporción de pacientes que consigue el objetivo de control de PA en cada brazo de tratamiento. Y el perfil de seguridad/tolerabilidad de SPP100. ;Primary end point(s): Comparar la eficacia de 300 mg de aliskiren una vez al día con 150 mg de aliskiren dos veces al día para reducir la media de presión arterial diastólica ambulatoria (MPADA) durante 24 horas, desde la situación basal al final del período 2 del estudio (semana 6) en pacientes con hipertensión esencial. | — |
Countries
Germany, Spain
Outcome results
None listed