hypertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients = 18 years of age 2. Patients with essential hypertension: • Naïve patients must have a msSBP = 150 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 ethics 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 within 12 months from visit 1 for 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 = 5.5 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 except for nitrates. 12. Second or third degree heart block without a pacemaker. 13. Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening arrhythmia during the 12 months prior to Visit 1. 14. Clinically symptomatic valvular heart disease at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate if initiating treatment with a combination is superior compared to the average of the sequential add-on treatment strategies in reduction of the overall mean over weeks 8, 16, and 24 in the change from baseline in msSBP 2. To evaluate under proof of principle that starting treatment with a combination regimen is superior compared to the average of the sequential add-on treatment strategies in final achieved reduction from baseline to week 24 in msSBP;Secondary Objective: Key secondary objectives are listed below. For full list, please refer to the protocol. • To compare the average change from baseline in msSBP over weeks 8, 16, and 24 between the starting combination group and the sequential add-on treatment groups • To compare the average change from baseline in mean sitting diastolic blood pressure (msDBP) over weeks 8, 16, and 24 between the starting combination group and the sequential add-on treatment groups (single and combined) • To compare the change from baseline in msSBP after 8, 16, and 32 weeks between the starting combination group and the sequential add-on treatment groups (single and combined) • To compare the change from baseline in msDBP after 8, 16, 24, and 32 weeks between the starting combination group and the sequential add-on treatment groups (single and combined);Primary end point(s): The primary efficacy variable for the first rank order hypothesis will be the overall mean of the changes from baseline in msSBP over the three time points: Weeks 8, 16 and 24. The primary efficacy variable for the second rank order hypothesis will be the change from baseline in msSBP at Week 24 (Visit 5). | — |
Countries
France, Germany, Greece, United Kingdom
Outcome results
None listed