Essential hypertension MedDRA version: 13.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Rasilez
Product Name: Rasilez
Product Code: SPP100
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ALISKIREN
CAS Number: 173334571
Current Sponsor code: SPP100
Concentration u
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, aged between 18 and 75 years (inclusive) at screening. 2. Female patients of childbearing potential must be using an acceptable form of contraception, Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to screening. Female patients who report surgical sterilization must have had the procedure at least six (6) months prior to screening. 3. All patients must be diagnosed at least 3 months prior to screening with either systolic or diastolic heart failure with signs and symptoms of congestive heart failure and NYHA functional class II or III symptoms AND be on stable medication for at least 12 weeks (furosemide only stable for 3 weeks) 4. A patient has to fulfill either a), or b) to qualify for participation (a) Patients with a documented left ventricular ejection fraction(LVEF) greater than 20% but lower than 40% (b) Patients with a documented left ventricular ejection fraction (LVEF) greater than 40% AND with a history of NT-pro-BNP > 400 pg/mL (or BNP > 100 pg/mL) within 12 months of screening. 5. Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) of maximum 40 kg/m2. 6. Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand and sign the written informed consent. For a detailed list of inclusion criteria, please refer to the full protocol. 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
Exclusion criteria: 1. Treatment with Angiotensin Receptor Blockers (ARBs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. Beta blockers are permitted providing the dose has been stable for at least 3 weeks before the first dose and remains so throughout the study. 2. Hypertrophic cardiomyopathy (HCMP). 3. If a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily. 4. Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase 2 (COX-2) inhibitors within 72 hours prior to first dose or during the 24 hour in-clinic study periods. 5. Treatment with sildenafil (Viagra), vardenafil (Levitra), or tadalafil (Cialis) within 72 hours prior to first dose or during the 24 hour in-clinic study periods. 6. Commencing any new medication during the conduct of the study that could affect renal function or serum creatinine. 7. Stable heart failure requiring treatment with both an ACE inhibitor and an ARB. 8. msSBP =160 mmHg and/or msDBP = 100mmHg and/or secondary forms of hypertension. 9. Persistent sitting systolic blood pressure <90 mmHg. 10. Signs or symptoms of dehydration (BUN/sCr ratio; orthostatic hypotension) as judged to be clinically significant by the investigator. 11. Uncontrolled diabetes based on the investigator’s clinical judgement, and glucose/HbA1c measurements. 12. History of angioedema. For a full list of exclusion criteria, please refer to the full protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the effect of single (150 mg) and multiple (150 mg and 300 mg) doses of aliskiren on the diuretic efficacy (efficacy index) of 80 mg furosemide at steady state.;Secondary Objective: •To assess the effect of multiple doses of aliskiren (150 mg and 300 mg) on the pharmacokinetics of 6xy0 mg furosemide. •To assess the effect of multiple doses of aliskiren (150 mg and 300 mg) on blood pressure when co administered with 80 mg furosemide at steady state. •To assess the effect of single and multiple doses of aliskiren (150 mg) on urinary sodium, urinary potassium, and creatinine clearance when co administered with 80 mg furosemide at steady state. ;Primary end point(s): - urinary sodium concentration in 0-4h and 0-24h urine collection fractions - urine volume in 0-4h and 0-24h urine collection fractions - urinary furosemide concentration in 0-4h and 0-24h urine collection fractions | — |
Countries
Germany, Lithuania, Russian Federation
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed