Estudio aleatorizado, doble ciego, de grupos paralelos, multicéntrico, para comparar la eficacia y seguridad de aliskiren 300 mg administrado una vez al día y de aliskiren 150 mg administrado dos veces al día en pacientes con hipertensión esencial

Active, not recruiting

• Conditions: Hipertension; MedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertension

• Registration Number: EUCTR2007-002469-11-ES
• Lead Sponsor: ovartis Farmaceutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-27
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 314

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified