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A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People

NCT01259297•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.

Detailed Description

This was 2x2 factorial design study with 2 strata. As per protocol, the first co- Primary analysis as well as secondary analysis were aliskiren based regimen vs non-aliskiren based regimen. All aliskiren based arm were combined into the aliskiren based regimen and all non-aliskiren based arms were combined into non-aliskiren based regimen.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3):
•1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease
•* Previous myocardial infarction or
•* Stable angina or unstable angina with documented multi-vessel coronary artery disease, \> 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or
•* Multi-vessel PCI, or
•* Multi-vessel CABG surgery \> 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA \< 1 year before informed consent Peripheral artery disease
•* Previous limb bypass surgery or percutaneous transluminal angioplasty, or
•* Previous limb or foot amputation, or
•* History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (\> 50%) documented by angiography or non-invasive testing
•* Diabetes mellitus: High-risk diabetics with evidence of end-organ damage
+8 more criteria

Exclusion Criteria

•1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to Aliskiren, Amlodipine or Hydrochlorothiazide.
•2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker. Patients on only one of these two classes of drugs are eligible
•3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
•4. Symptomatic heart failure, requiring the use of loop diuretics
•5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease.
•6. Acute stroke \< 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome \< 1 months before informed consent
•7. Planned cardiac surgery or angioplasty \< 3 months after informed consent or having had the procedure \< 3 months before informed consent
•8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L
•9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST \> 3x upper limit of normal (ULN)
•10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR \< 60 ml/min/1.73m2 (MDRD formula)
+2 more criteria

Locations (185)

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Northridge, California, United States

Novartis Investigative Site

Sylmar, California, United States

Novartis Investigative Site

Tucker, Georgia, United States

Novartis Investigative Site

Pocatello, Idaho, United States

Novartis Investigative Site

Haverhill, Massachusetts, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Westfiled, New York, United States

Novartis Investigative Site

Winston-Salem, North Carolina, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

November 1, 2012

Completion Date

November 1, 2012

Last Updated

April 8, 2014

Enrollment

2,336

ACTUAL participants

Conditions

Cardiovascular Events

Interventions

Aliskiren

DRUG

Amlodipine

DRUG

Hydrochlorothiazide (HCTZ)

DRUG

Placebo for Aliskiren

DRUG

Placebo for Amlodipine

DRUG

Placebo for Hydrochlorothiazide (HCTZ)

DRUG

PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI

NCT05457582

Acute Coronary SyndromeHyperlipidemias+2 more

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People

Inclusion Criteria

Exclusion Criteria

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