Essential Hypertension
Conditions
Interventions
Trade Name: Rasilez
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: Rasilez
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. NYHA class IV Congestive Heart Failure at Visit 1 (CSPP100A2340 ”Core” Study Visit 10). 2. Symptomatic hypotension, or reported systolic BP 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this 2 year extension study (CSPP100A2340E1) is to provide additional long-term safety data in this patient population as a post marketing commitment to the EMEA. ;Secondary Objective: A secondary objective is to provide additional follow-up data on the effect of aliskiren on left ventricular remodeling as measured by echocardiography - left ventricular end systolic volume (LVESV), left ventricular end diastolic volume (LVEDV), and left ventricular ejection fraction (LVEF).;Primary end point(s): To provide additional lonog-term Safety Data | — |
Countries
Belgium, Czech Republic, Denmark, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed