hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients 18 years of age and older. 2. Male or female patients are eligible. 3. Patients with a diagnosis of hypertension: • Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP = 95 mmHg and =65 years) yes 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 within 12 months prior to Visit 1 of the following: 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. Patients with diabetes mellitus enrolled in this study should be well controlled. 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 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 |
|---|---|
| Primary end point(s): The primary efficacy variable is change from baseline (Visit 5) in mean sitting diastolic blood pressure (msDBP). The primary analysis timepoint is end of study using last observation carried forward as defined in Section 10.4.3 referred to as the Endpoint measurement.;Main Objective: Demonstrate the efficacy of the combination therapies of aliskiren/amlodipine (150/10 mg and 300/10 mg), in hypertensive patients who do not adequately respond to a 4-week treatment of amlodipine 10 mg by testing the hypothesis of superior reduction in mean sitting diastolic blood pressure (msDBP) from baseline to end of study when compared to amlodipine 10 mg monotherapy.;Secondary Objective: Key secondary objectives are listed below. For full list, please refer to the protocol. • Evaluate the efficacy of the combination therapies of aliskiren /amlodipine (150 / 10 mg and 300/10 mg) in hypertensive patients who do not adequately respond to a 4-week treatment of amlodipine 10 mg, by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (msSBP) from baseline to end of study when compared to amlodipine 10 mg monotherapy. • Evaluate the safety and tolerability of the combinations of aliskiren /amlodipine (150/10 mg and 300/10 mg) compared, with amlodipine 10 mg monotherapy in hypertensive patients who do not show an adequate blood pressure response to a 4-week treatment of amlodipine 10 mg. • Evaluate the proportion of patients achieving a blood pressure control target of < 140 / 90 mmHg at the end of study for all treatment arms. • Assess whether the combinations of aliskiren/amlodipine attenuate amlodipine induced edema. | — |
Countries
Germany, Slovakia, Sweden
Outcome results
None listed