hypertension MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients 18 years of age or older. 2. Patients must have a msDBP = 90 mmHg and =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For full list, please refer to the protocol. 1. Patients previously treated in an aliskiren study that contained the treatment group of the combination of aliskiren and amlodipine and had been randomized or enrolled into the active drug treatment period of that study. 2. Severe hypertension (msDBP =110 mmHg and/or msSBP = 180 mmHg). 3. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (= 5 mIU/ml). 4. 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 are using two birth control methods. The two methods can be a double barrier method (if accepted by local ethnics committee) or a barrier method plus a hormonal method. • Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. • Reliable contraception should be maintained throughout the study and for 7 days after the study. • Woman are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml [for US only: and estradiol <20 pg/ml] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. 5. History or evidence of a secondary form of hypertension. 6. Known Keith-Wagener grade III or IV hypertensive retinopathy. 7. Any history of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 8. Previous or current diagnosis of heart failure (NYHA Class II-IV). 9. Serum potassium = 5.3 mEq/L (mmol/L) at Visit 1. 10. Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator's clinical judgment. It is recommended that patients currently being treated for diabetes mellitus be on stable dose of antidiabetic medication for at least 4 weeks prior to Visit 1. 11. Current angina pectoris requiring pharmacological therapy (use of nitrates for the treatment of angina will be allowed). 12. Second or third degree heart block without a pacemaker, or potentially life-threatening arrhythmia during the 12 months prior to Visit 1. 13. Clinically symptomatic valvular heart disease at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate that the efficacy of the fixed-dose combination of aliskiren / amlodipine is superior to both monotherapies in patients with essential hypertension by testing the hypothesis of superior reduction in msDBP from baseline to end of study when compared with monotherapy across the doses in the study.;Secondary Objective: For full list, please refer to the protocol. Key secondary objectives are listed below: • Demonstrate that the efficacy of the fixed-dose combination of aliskiren / amlodipine is superior to both monotherapies in patients with essential hypertension by testing the hypothesis of superior reduction in msSBP from baseline to end of study when compared with monotherapies across the doses in the study. • Assess the safety of the fixed-dose combinations of aliskiren / amlodipine (150/5 mg, 150/10 mg, 300/5 mg, and 300/10 mg) in patients with essential hypertension. • Evaluate the 24-hour blood pressure profile of patients with aliskiren alone, and in combination with amlodipine by utilizing 24-hour Ambulatory Blood Pressure Monitoring (ABPM) in a subset of patients. • Assess whether the combinations of aliskiren/amlodipine attenuate amlodipine induced edema. ;Primary end point(s): The primary efficacy variable is change from baseline (Visit 3) in mean sitting diastolic blood pressure. The primary analysis will be conducted in change from baseline to the end of study (endpoint). For each patient, the last post-baseline measurement during the double-blind period will be carried forward as the endpoint measurement for the variable to be analyzed. | — |
Countries
Denmark, Finland, Greece, Italy, Spain, Sweden
Outcome results
None listed