An 8 week, double-blind, randomized, parallel group, active-controlled study to evaluate the efficacy and safety of the combination of Aliskiren /Amlodipine / HCTZ in patients with moderate to severe hypertension.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1160

Inclusion Criteria

1. Outpatients 18 years of age or older
2. Male or female patients are eligible.
3. msDBP & msSBP Requirements:
3A:
• Diagnosis of moderate to severe hypertension (msSBP = 160 mmHg and < 200 mmHg, and/or msDBP = 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6 (Qualifying BP visit)
• In addition, at the visit immediately prior to the above qualifying visit, patients must also have msSBP = 145 mmHg and < 200 mmHg and msDBP = 95 mmHg and < 120 mmHg) at Visits 3, 4 or 5
• Patients must meet the above two sets of requirements at subsequent adjacent visits, i.e., either Visits 3 and 4, Visits 4 and 5, or Visits 5 and 6
OR
3B:
• msSBP = 180 mmHg and < 200 mmHg with msDBP = 95 mmHg and < 120 mmHg, or msDBP = 110 mmHg and < 120 mmHg with msSBP = 150 mmHg and < 200 mmHg after at least one week of treatment with placebo (Visit 3 and on)
4. For patients requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase (placebo period) of the study.
5. 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
;
1. Outpatients 18 years of age or older
2. Male or female patients are eligible.
3. msDBP & msSBP Requirements:
3A:
• Diagnosis of moderate to severe hypertension (msSBP = 160 mmHg and < 200 mmHg, and/or msDBP = 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6 (Qualifying BP visit)
• In addition, at the visit immediately prior to the above qualifying visit, patients must also have msSBP = 145 mmHg and < 200 mmHg and msDBP = 95 mmHg and < 120 mmHg) at Visits 3, 4 or 5
• Patients must meet the above two sets of requirements at subsequent adjacent visits, i.e., either Visits 3 and 4, Visits 4 and 5, or Visits 5 and 6
OR
3B:
• msSBP = 180 mmHg and < 200 mmHg with msDBP = 95 mmHg and < 120 mmHg, or msDBP = 110 mmHg and < 120 mmHg with msSBP = 150 mmHg and < 200 mmHg after at least one week of treatment with placebo (Visit 3 and on)
4. For patients requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase (placebo period) of the study.
5. 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. Inability to discontinue all prior antihypertensive medications at Visit 2 (start of placebo) or complete the taper within 4 weeks after Visit 1.
2. Patients with an msSBP = 200 mmHg or msDBP = 120 mmHg at any time during the placebo run-in period must be discontinued from the study.
3. Patients on four or more antihypertensive drugs at Visit 1.
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 (= 10 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 meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception such as surgical sterilization (e.g., bilateral tubal ligation) or hormonal contraception (implantable, patch, oral), or double-barrier methods (if accepted by the local Health Authority and Ethics Committee) Reliable contraception should be maintained throughout the study and for 7 days after study medication discontinuation.
6. History or evidence of a secondary form of hypertension.
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 = 5.5 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 with or without a pacemaker, atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening arrhythmia during the 12 months prior to Visit 1.

;
For full list, please refer to the protocol.

1. Inability to discontinue all prior antihypertensive medications at Visit 2 (start of placebo) or complete the taper within 4 weeks after Visit 1.
2. Patients with an msSBP = 200 mmHg or msDBP = 120 mmHg at any time during the placebo run-in period must be discontinued from the study.
3. Patients on four or more antihypertensive drugs at Visit 1.
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 (= 10 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 meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception such as surgical sterilization (e.g., bilateral tubal ligation) or hormonal contraception (implantable, patch, oral), or double-barrier methods (if accepted by the local Health Authority and Ethics Committee) Reliable contraception should be maintained throughout the study and for 7 days after study medication discontinuation.
6. History or evidence of a secondary form of hypertension.
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 = 5.5 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 with or without a pacemaker, atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening arrhythmia during the 12 months prior to Visit 1.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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