Hypertension
Conditions
Interventions
Product Name: Aliskiren
Product Code: SPP100
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Aliskiren
CAS Number: 173334-58-2
Current Sponsor code: SPP100
Concentration unit: mg milligra
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (For Full list, see protocol) - Outpatients 18 years of age and older. - Male or female patients are eligible. - 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 85 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (For Full list, see protocol) - Pregnant or nursing (lactating) women - Women of child-bearing potential (WOCBP) - Severe hypertension (msDBP = 110 mmHg and/or msSBP = 180 mmHg). - History or evidence of a secondary form of hypertension. - Known Keith-Wagener grade III or IV hypertensive retinopathy. - Previous or current diagnosis of heart failure. - History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). - Serum potassium 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. - Current treatment with cholestyramine or colestipol resins. - History of hypersensitivity to any of the medications or to drugs belonging to the similar therapeutic class (ARB’s, ACE-I’s, thiazide diuretics, or other sulfonamide derived drugs) as the medications. - History of angioedema due to usage of an ACE-I or ARB. - History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. - History of gouty arthritis. - History or evidence of drug or alcohol abuse within the last 12 months. - Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. - Patients who previously participated in a clinical trial that contained the treatment combination of aliskiren/HCTZ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the efficacy of the combination therapy of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of aliskiren 300 mg by testing the hypothesis of superior reduction in mean sitting diastolic blood pressure (msDBP) from baseline to end of study when compared to aliskiren 300 mg monotherapy.;Secondary Objective: - Evaluate the efficacy of the combination therapy of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of aliskiren 300 mg by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (msSBP) from baseline to end of study when compared to aliskiren 300 mg monotherapy. - Evaluate the safety and tolerability of the combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) compared with aliskiren 300 mg monotherapy in hypertensive patients who do not show sufficient blood pressure response to a 4- week treatment of aliskiren 300 mg. - Evaluate the proportion of patients achieving a blood pressure control target of < 140 / 90 mmHg at the end of study for all treatment arms;Primary end point(s): The primary efficacy variable is change from baseline (visit 5) in mean sitting diastolic blood pressure. For each patient, the last post-baseline measurement during the double-blind period will be carried forward to Week 8 as the endpoint measurement for the variable to be analyzed. The primary analysis timepoint will be the endpoint. | — |
Countries
Germany, Italy
Outcome results
None listed