Treatment of essential hypertension
Conditions
Interventions
Product Name: Aliskiren
Product Code: SPP100
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Aliskiren
CAS Number: 173334-58-2
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Novartis Sverige AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with essential hypertension. Patients must have a MSDBP =90 mmHg and=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients previously treated with aliskiren • Severe hypertension (grade 3 WHO classification; 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. • History of hypertensive encephalopathy or cerebrovascular accident • Transient ischemic cerebral attack during the 12 months prior to Visit 1. • Current diagnosis of heart failure (NYHA Class II-IV) • History of myocardial infarction, coronary bypass surgery, or any percutaneaous coronary intervention (PCI) during the 12 months prior to Visit 1. • Current angina pectoris requiring pharmacological therapy (other than sublingual nitroglycerin). • Second or third degree heart block without a pacemaker. • Concurrently potentially life threatening arrhythmia or symptomatic arrhythmia. • Clinically significant valvular heart disease. • Type 1 or Type 2 diabetes mellitus with poor glycemic control defined as fasting glycosylated hemoglobin (HbA1c) >9% at Visit 1. • Serum sodium and/or serum potassium less than the lower limit of normal, dehydration, or hyperkalemia =5.5 mEq/L at Visit 1. • 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. • Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1. • Currently active gastritits, duodenal or gastric ulcers, or gastrointestinal/rectal 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. • Evidence of hepatic disease as determined by any one of the following: SGOT or SGPT values exceeding 2 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt. • Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. • History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. • History or evidence of drug or alcohol abuse within the last 12 months. • Pregnant or nursing women. • 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. • Known or suspected contraindications to the study medications, including history of allergy to thiazide diuretics or other sulfonamide derived drugs. • History of gouty arthritis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to: • Confirm the efficacy of aliskiren 75 mg, 150 mg and 300 mg in patients with essential hypertension by testing the hypothesis of superior reduction in MSDBP from baseline to study end when compared to placebo. • Demonstrate the efficacy of the combination of aliskiren and HCTZ 75/6.25 mg, 75/12.5 mg, 150/6.25 mg, 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg in patients with essential hypertension by testing the hypothesis of superior reduction in MSDBP from baseline to study end when compared to the component monotherapies. ;Secondary Objective: • Demonstrate the antihypertensive dose response effect of aliskiren alone and in combination with HCTZ by testing the hypothesis that the magnitude of MSDBP and MSSBP reduction are related to the dose level of aliskiren and HCTZ administered in this study population. • Explore the safety and tolerability of aliskiren 75 mg, 150 mg and 300mg, given alone and in combination with HCTZ, in patients with essential hypertension. ;Primary end point(s): The primary efficacy variable is change from baseline (Visit 3) in mean sitting diastolic blood pressure. The primary analysis will be conducted in change from baseline to the end of study (endpoint). For each patient, the last post-baseline measurement during the double-blind period will be carried forward as the endpoint measurement for the variable to be analyzed. | — |
Countries
Finland, Italy, Sweden
Outcome results
None listed