hypertension MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range ;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 =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. 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. ;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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that a once daily dosing regimen of the triple combination of aliskiren/amlodipine/HCTZ is superior to the double combinations of aliskiren/amlodipine, aliskiren/HCTZ and amlodipine/HCTZ in lowering mean sitting systolic blood pressure (msSBP) in patients with moderate to severe hypertension.;Secondary Objective: Key secondary objectives are listed below. For full list, please refer to the protocol. • To demonstrate that a once daily dosing regimen of the triple combination of aliskiren/amlodipine/HCTZ is superior to the double combinations of aliskiren/amlodipine, aliskiren/HCTZ and amlodipine/HCTZ in lowering mean sitting diastolic blood pressure (msDBP) in patients with moderate to severe hypertension. • To evaluate the decrease in 24-hour mean ambulatory diastolic and systolic blood pressures produced by the triple combination of aliskiren/HCTZ/amlodipine in comparison to the double combinations of aliskiren/HCTZ, aliskiren/amlodipine, or HCTZ/amlodipine in patients with moderate to severe hypertension. • To evaluate the safety and tolerability of the triple combination of aliskiren/HCTZ/amlodipine in comparison to the double combinations of aliskiren/HCTZ, aliskiren/amlodipine and HCTZ/amlodipine in patients with moderate to severe hypertension.;Primary end point(s): The primary efficacy variable is change from baseline in msSBP. msSBP is the average of available readings of sitting systolic blood pressure for a given visit. The primary analysis time point will be the Week 8 endpoint. For each patient, the last post-baseline measurement during the double-blind treatment period will be carried forward to Week 8 as the Week 8 endpoint measurement. ;Main Objective: The primary objective of the study is to demonstrate that a once daily dosing regimen of the triple combination of aliskiren/amlodipine/HCTZ is superior to the double combinations of aliskiren/amlodipine, aliskiren/HCTZ and amlodipine | — |
Countries
Denmark, Germany, Italy, Latvia, Lithuania, Sweden
Contacts
Public Contact; ;
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Outcome results
None listed