Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2013-001562-42-ES
EUCTR2013-001562-42-ESActive, not recruitingNot Applicable

A randomized, double-blind, parallel group, active-controlled study to compare the systolic blood pressure lowering efficacy of aliskiren, ramipril and a combination of aliskiren and amlodipine, with an initial 8-week evaluation, followed by a 2-3 year follow-up to compare long-term safety of an aliskiren-based regimen to a ramipril-based regimen in hypertensive patients ? 65 years of age. - ASSESS

ovartis Farmacéutica, S.A.0 sites1,392 target enrollmentStarted: November 12, 2013Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
1,392
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 range).
  • •28.History or evi

Investigators

Sponsor
ovartis Farmacéutica, S.A.

Similar Trials

Active, not recruiting
Not Applicable
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
EUCTR2013-001562-42-HUovartis Pharma Services AG1,392
Active, not recruiting
Not Applicable
A randomized, double-blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus an amlodipinetreatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy - NDMedDRA version: 6.1Level: PTClassification code 10015488Essential hypertension
EUCTR2005-000684-26-ITOVARTIS FARMA1,244
Active, not recruiting
Not Applicable
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 regimeessential hypertensionMedDRA version: 17.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders
EUCTR2013-001562-42-PLovartis Pharma Services AG1,392
Active, not recruiting
Not Applicable
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 regimeEssential hypertensionMedDRA version: 16.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders
EUCTR2013-001562-42-SKovartis Pharma Services AG1,392
Active, not recruiting
Not Applicable
Clinical trial to evaluate if SKP-021, a 0.3% ketoprofen patch has an efficacy at least equal to diclofenac sodium patch in patients with back pain, bruise, contusion, sprain, strains
EUCTR2011-005661-20-ITPROMO INTERNATIONAL SR