A twelve-week, randomized, double-blind, multi-center, placebo controlled, parallel group study to evaluate the safety and efficacy of aliskiren 150 mg when added to standard therapy in hypertensive patients with stable heart failure

• Register: EUCTR
• Last refreshed on: 21 January 2013
• Main ID: EUCTR2004-004014-16-ES
• Date of registration: 05/12/2005
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A twelve-week, randomized, double-blind, multi-center, placebo controlled, parallel group study to evaluate the safety and efficacy of aliskiren 150 mg when added to standard therapy in hypertensive patients with stable heart failure
• Scientific title: A twelve-week, randomized, double-blind, multi-center, placebo controlled, parallel group study to evaluate the safety and efficacy of aliskiren 150 mg when added to standard therapy in hypertensive patients with stable heart failure
• Date of first enrolment: 04/01/2006
• Target sample size: 280
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004014-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: yes Cross over: Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: Other:

Countries of recruitment

Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
• Outpatients 18 years of age and older.
• Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
• Patients with history or current diagnosis of essential hypertension
• Patients with stable heart failure (NYHA Class II-IV), for at least 1 month prior to Visit 1. Patients must be on a stable dosage regimen of heart failure medications which may consist of the following: either an ACE inhibitor OR an ARB, and a beta blocker for the 1 month period prior to Visit 1. For patients not on either an ACE inhibitor OR an ARB, and a beta blocker at entry the reason (e.g., patient is intolerant of these medications or the absence of a clinical indication) should be documented. The use of digoxin and diuretics as background therapy for heart failure is allowed.
• Patients with a BNP > 150 pg/ml (43 pmol/L) at Visit 1.
• Patients with documented sinus rhythm at Visit 1.
• Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

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:
• Patients with stable heart failure who require treatment with both an ACE inhibitor and an ARB
• Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period.
• History or evidence of a secondary form of hypertension
• Right heart failure due to pulmonary disease.
• Diagnosis of postpartum cardiomyopathy.
• Hemodynamically significant mitral stenosis or lesions of the left ventricular outflow tract including aortic stenosis or hypertrophic obstructive cardiomyopathy.
• Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infective cardiomyopathy (e.g., Chagas’ disease).
• Patients with a history of heart transplant or who are on a transplant list (life expectancy < 6 months at time of entry into the study).
• Persistent sitting systolic blood pressure < 90 mm Hg.
• Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA during the 14 weeks of the trial. Patients with angina pectoris requiring pharmacological therapy are allowed entry into the study.
• History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1.
• Second or third degree heart block without a pacemaker.
• Patients with chronic atrial fibrillation.
• Patients with an ICD or pacemaker where patient uses pacemaker > 20% of the time.
• Patients with a biventricular pacemaker or biventricular ICD.
• Episode(s) of ventricular tachycardia or another severe arrhythmia producing significant hemodynamic consequences or considered life-threatening within 3 months of Visit 1.
• Patients who require treatment with Vaughn Williams Type 1 or 3 anti-arrhythmic agents within 30 days prior to Visit 1 or who may require them anytime during the study are to be excluded (note: the use of amiodarone is permitted if the patient has been on a stable does for at least 30 days prior to Visit 1).
• Transient ischemic cerebral attack or cerebral vascular accident during the 6 months prior to Visit 1.
• Patients with active or unstable bronchospasm or asthma (patients must be on stable regimen of respiratory medications for 1 month prior to Visit 1).
• Serum potassium = 5.1 mEq/L (5.1 mmol/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 gastritis, 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 3 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 > 2.0 mg/dL (177 umol/L) at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
• Current treatment with cholestyramine and colestipol resins.
• History of malignancy i

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Product Name: Aliskiren
Pharmaceutical Form: Tablet
INN or Proposed INN: Aliskiren
CAS Number: 173334-58-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Evaluate the overall safety and tolerability of aliskiren 150 mg when given in addition to standard therapy in hypertensive patients with stable heart failure

Main Objective: • Evaluate the overall safety and tolerability of aliskiren 150 mg when given in addition to standard therapy in hypertensive patients with stable heart failure.

Secondary Objective: • Evaluate the efficacy of aliskiren on N-terminal pro-brain natriuretic peptide when added to standard therapy in hypertensive patients with stable heart failure.
• Evaluate the efficacy of aliskiren on brain natriuretic when added to standard therapy in hypertensive patients with stable heart failure.
• Evaluate the efficacy of aliskiren on aldosterone when added to standard therapy in hypertensive patients with stable heart failure.
• Evaluate the effect of aliskiren on improvement in signs and symptoms of heart failure and change in NYHA classification from baseline to study end.
• Evaluate the effect of aliskiren on cardiac hemodynamics as assessed by echocardiography at baseline and end of study.
• Evaluate the blood pressure lowering effect (change from baseline in MSSBP and MSDBP) of aliskiren 150 mg in hypertensive patients with stable heart failure.

Secondary ID(s)

2004-004014-16-GB

CSPP100A2313