study to compare the blood pressure lowering efficacy of aliskiren, a combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to moderate hypertension. It will also compare the long-term safety of an aliskiren-based regimen to a ramipril-based regime

• Conditions: essential hypertension; MedDRA version: 16.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001562-42-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-21
• Last Update Posted: 31 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1392

Inclusion Criteria

Inclusion Criteria: -Patients = 65 years of age with a clinical diagnosis of essential
hypertension at Visit 1.
-Mean sitting SBP (MSSBP) = 140 mmHg and < 180 mmHg at Visit 2/Visit 201 and Visit 3. –Absolute MSSBP difference = 20 mmHg between Visit 3 and the Visit immediately prior
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 1392

Exclusion Criteria

1.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
2.Severe hypertension (MSSBP = 180 mmHg or MSDBP = 110 mmHg) at Visit 1, Visit 2, Visit 201 or Visit 3 or during patient self measured blood pressure (SMBP) monitoring in the pre-randomization period confirmed by office measurement.
3.Current treatment with any blocker of the RAAS (aliskiren, ACEI, ARB or an aldosterone antagonist) and unable to discontinue this therapy.
4.Concurrent use of any anti-hypertensive medications except a stable dose of 3 months prior to Visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., tamsulosin [Flomax®] for benign prostatic hypertrophy [BPH]), beta blockers for angina, or beta blocker ophthalmic preparations.
5.Contraindications to aliskiren, ramipril, amlodipine, or HCTZ.
6.History of renal artery stenosis.
7.Known retinopathy.
8.History of hypertensive encephalopathy.
9.Known ejection fraction = 40%.
10.Current diagnosis of heart failure (NYHA Class III-IV).
11.History of transient ischemic cerebral attack (TIA) or cerebrovascular accident (CVA) within 6 months.
12.History of myocardial infarction, bypass surgery (CABG), or any percutaneous coronary intervention (PCI) within 6 months.
13.History of acute gouty arthritis within the last 3 years.
14.Serum sodium less than the lower limit of normal (minus 10 percent) or dehydration at Visit 1.
15.Serum potassium less than 3.5 mEq/L (corresponding to 3.5 mmol/L), or more than 5.2 mEq/L (corresponding to 5.2 mmol/L) at Visit 1.
16.Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates for angina are acceptable.
17.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
18.Clinically significant valvular heart disease.
19.Evidence of renal impairment: eGFR < 60 ml/min/1.73m2 as estimated by the Modification of Diet in Renal Disease (MDRD) or the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equations using serum creatinine measured by an Isotope Dilution Mass Spectrometry (IDMS)-traceable creatinine assay at Visit 1.
20.Evidence of nephrotic range proteinuria as indicated by proteinuria > 3500 mg/day per 1.73m2 body surface area or nephrotic syndrome.
21.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
22.Unstable type 2 diabetes mellitus (stable diabetes mellitus is defined as diabetes in patients on a stable regimen of diet and, if required, a stable dose of oral anti-diabetics and/or insulin during the last 3 month).
23.Concurrent treatment with cyclosporine, quinidine or systemic use of conazoles (e.g. itraconazole), except ketoconazole and voriconazole.
24.Any condition that in the opinion of the investigator or the Novartis Medical Monitor would confound the evaluation and interpretation of efficacy and/or safety data.
25.History of inflammatory bowel disease of the colon and small intestine (Crohn’s disease and ulcerative colitis).
26.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
27.History of chronic liver disease or abnormal ALT/SGPT (> 3 times the upper limit of the reference range) or total bilirubin (> 2 times the upper limit of the reference

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified