A randomized, eight week double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / amlodipine (150/10 mg and 300/10 mg) in comparison with amlodipine 10 mg in patients with essential hypertension not adequately responsive to amlodipine 10 mg monotherapy.

Conditions: hypertension

Registration Number: EUCTR2006-006068-44-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 726

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 < 110 mmHg at Visits 1 and 2.
• Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP = 90 mmHg and < 110 mmHg at Visit 2.
• All patients must have a msDBP = 90 mmHg and < 110 mmHg at Visit 5.
4. Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation 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

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.