patients with essential hypertension and metabolic syndrome.
Conditions
Interventions
Product Name: Aliskiren
Product Code: SPP100
Pharmaceutical Form: Tablet
INN or Proposed INN: Aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmac
Sponsors
Novartis Pharmaceuticals UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients 18-70 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 MSBBP = 140 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any of the following at Visit 1, Visit 2, Visit 3 (unless otherwise stated) will be excluded from participation in the study. 1. Previously treated in an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (= 5 mIU/ml). 3. 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/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. 4. Patients currently on antihypertensive medication(s) that require tapering of > 7 days at Visit 1. 5. Severe hypertension (an office cuff MSDBP = 115 mmHg and/or MSSBP = 180 mmHg). 6. History or evidence of a secondary form of hypertension. 7. Known Keith-Wagener grade III or IV hypertensive retinopathy. 8. Previous or current diagnosis of heart failure (NYHA Class II-IV). 9. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 10. Serum sodium < 135 mEq/ L (mmol/L) at Visit 1, if confirmed on repeat sample. 11. Serum potassium < 3.5 mEq/L (mmol/L) or = 5.3 mEq/L (mmol/L) at Visit 1, if confirmed on repeat sample. 12. Type 1 diabetes mellitus. 13. Type 2 diabetes mellitus if change in oral hypoglycaemic in previous 3 months.. 14. Current angina pectoris requiring pharmacological therapy. 15. Second or third degree heart block without a pacemaker. 16. Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1. 17. Clinically significant valvular heart disease. 18. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following: • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection. • History of active inflammatory bowel disease during the 12 months prior to Visit 1. • Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal bleeding during the 3 months prior to Visit 1. • Any history of pancreatic injury, pancreatitis, or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase during the 12 months prior to Visit 1. • Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ;Main Objective: The primary objectives of this study are: 1. To demonstrate that the combination of aliskiren / ramipril / amlodipine (300/10/10 mg) has superior efficacy compared to the combinations of ramipril / amlodipine (10/10 mg) in reducing MSSBP from baseline to the end of 12 weeks of treatment in patients with hypertension and metabolic syndrome not adequately responsive to amlodipine 10 mg. 2. To demonstrate that the combination of aliskiren / amlodipine (300/10 mg) has non-inferior efficacy compared to the combinations of ramipril / amlodipine (10/10 mg) in reducing MSSBP from baseline to the end of 12 weeks of treatment in patients with hypertension and metabolic syndrome not adequately responsive to amlodipine 10 mg. ;Secondary Objective: The secondary objectives of this study are: 1. To evaluate whether the combination of aliskiren / ramipril / amlodipine (300/10/10 mg) has superior efficacy compared to the combination of ramipril / amlodipine (10/10 mg) in reducing MSDBP from baseline to the end of 12 weeks of treatment in patients with hypertension and metabolic syndrome not adequately responsive to amlodipine 10 mg. 2. To evaluate whether the combination of aliskiren / amlodipine (300/10 mg) has superior efficacy compared to the combination of ramipril / amlodipine (10 / 10 mg) in reducing MSDBP and MSSBP from baseline to the end of 12 weeks of treatment in patients with hypertension and metabolic syndrome not adequately responsive to amlodipine 10 mg. 3. To compare changes in HbA1c at 12 weeks from baseline. 4. To evaluate the safety and tolerability profile of all treatment groups. 5. To evaluate the proportion of patients achieving a blood pressure control target of < 140/90 mmHg in each treatment arm. | — |
Countries
United Kingdom
Outcome results
None listed