A 2 year extension to a 36-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarction patients when added to optimized standard therapy

Conditions: Essential Hypertension
MedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertension

Registration Number: EUCTR2008-001306-16-GB

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1. Patients that complete the CSPP100A2340 Core” study through Visit 10, while on double-blind study drug. 2. Patients who are able to participate in the study, and who consent to do so after the purpose and nature of the study 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

1. NYHA class IV Congestive Heart Failure at Visit 1 (CSPP100A2340 ”Core” Study Visit 10). 2. Symptomatic hypotension, or reported systolic BP < 90 mmHg within the 24 hours prior to Visit 1 (CSPP100A2340 ”Core” Study Visit 10). 3. Known Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the MDRD formula at Visit 1 (CSPP100A2340 Core” Study Visit 10). 4. 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). 5. 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 or tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) if accepted by local ethics committees. Reliable contraception should be maintained throughout the study and for at least 7 days after study drug discontinuation. 6. Any surgical or medical condition that in the opinion of the investigator may place the patient at higher risk from his/her participation in the study or is likely to prevent the patient from complying with the requirements or completing the study.