An 8-week, double-blind, randomized, parallel group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren 300 mg and amlodipine 10 mg compared to amlodipine 10 mg in patients with moderate to severe hypertension.

• Conditions: Hypertension; MedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertension

• Registration Number: EUCTR2008-005216-40-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-31
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

1. Outpatients =18 years of age.
2. Patients with a diagnosis of moderate to severe hypertension, defined as msSBP = 160 mmHg and < 200 mmHg at Visit 2.
3. Patients who are eligible, 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.
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 defined as msSBP = 200 mmHg and/or msDBP = 120 mmHg.
3. Patients on a combination of 3 or more antihypertensive medications. Fixed combination of 2 drugs will be considered as 2 drugs.
4. 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).
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 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.
6. History or evidence of a secondary form of hypertension.
7. Known Keith-Wagener grade III or IV hypertensive retinopathy.
8. 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) within 12 months prior to Visit 1.
9. Previous or current diagnosis of heart failure (NYHA Class II-IV).
10. Serum potassium = 5.3 mEq/L (mmol/L) at Visit 1.
11. 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 to Visit 1.
12. Current angina pectoris requiring pharmacological therapy (use of nitrates for the treatment of angina will be allowed).
13. Second or third degree heart block without a pacemaker.
14. Atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening arrhythmia during the 12 months prior to Visit 1.
15. Clinically symptomatic valvular heart disease at Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified