Aliskiren

Generic Name: Aliskiren

Brand Names: Rasilez, Tekturna, Tekturna Hct

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₅₃N_₃O_₆

CAS Number: 173334-57-1

Unique Ingredient Identifier: 502FWN4Q32

Background: Aliskiren is the first drug in the renin inhibitor drug class and is used for the treatment of hypertension. It was developed by Speedel and Novartis and initially approved by the FDA in early 2007. Aliskiren has been proven to efficacious in reducing blood pressure when used alone or in conjunction with other antihypertensive agents.

Indication: Aliskiren is used for the treatment of hypertension in children above 6 years and adults. This drug may also be used in conjunction with antihypertensives such as calcium channel blockers and thiazides in products form to provide additional blood pressure control.

Associated Conditions: Hypertension

Clinical Trials

Treatment of Adiposity Related hypErTension (TARGET)

Phase 4

Completed

Conditions: Hypertension
Abdominal Obesity
Metabolic Syndrome

Interventions: Drug: Hydrochlorothiazide
Drug: Aliskiren
Drug: Moxonidine
Drug: Placebo (for moxonidine and hydrochlorothiazide)
Drug: Placebo (for aliskiren)

First Posted Date: 2010-06-07

Last Posted Date: 2012-02-24

Lead Sponsor: UMC Utrecht

Target Recruit Count: 32

Registration Number: NCT01138423

Locations: 🇳🇱
UMC Utrecht, Utrecht, Netherlands

Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease

Phase 4

Terminated

Conditions: Proteinuric Kidney Disease
Diabetic Nephropathy
Hypertensive Nephrosclerosis
IgA Nephropathy
Focal Segmental Glomerulosclerosis
Glomerulopathy (Obesity-associated)
Glomerulonephritis, Membranous

Interventions: Drug: Aliskiren
Drug: Valsartan

First Posted Date: 2010-05-24

Last Posted Date: 2014-05-15

Lead Sponsor: Columbia University

Target Recruit Count: 46

Registration Number: NCT01129557

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States

A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure

Phase 2

Completed

Conditions: Heart Failure

Interventions: Drug: Furosemide 60 mg
Drug: Aliskiren 150 mg
Drug: Placebo for Aliskiren
Drug: Aliskiren 300 mg

First Posted Date: 2010-05-18

Last Posted Date: 2012-09-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 37

Registration Number: NCT01125514

Locations: 🇱🇹
Novartis Investigative Site, Vilnius, Lithuania

Aldosterone and the Metabolic Syndrome

Phase 1

Completed

Conditions: Diabetes Mellitus
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases

Interventions: Drug: Hydrochlorothiazide (HCTZ)
Drug: Aliskiren 150 mg (ALI 150)
Drug: Aliskiren 300 mg (ALI 300)
Drug: Spironolactone (SPL 25)
Drug: Spironolactone 50 mg (SPL 50)

First Posted Date: 2010-04-14

Last Posted Date: 2018-11-05

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 69

Registration Number: NCT01103245

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Effects of Valsartan and Aliskiren on Hemostatic Indices in Hypertensive Diabetics

Phase 4

Conditions: Diabetes Mellitus

Interventions: Drug: Aliskiren + Valsartan

First Posted Date: 2010-03-30

Last Posted Date: 2010-03-30

Lead Sponsor: HeartDrug Research LLC

Target Recruit Count: 50

Registration Number: NCT01095822

Locations: 🇺🇸
Dr. Pokov's Polyclinic. 6821 Reisterstown Road Suite 206, Baltimore, Maryland, United States

Aliskiren in Patients With Idiopathic Membranous Nephropathy

Not Applicable

Withdrawn

Conditions: Idiopathic Membranous Nephropathy

Interventions: Drug: Aliskiren

First Posted Date: 2010-03-26

Last Posted Date: 2013-03-13

Lead Sponsor: Mayo Clinic

Registration Number: NCT01093781

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis

Phase 3

Terminated

Conditions: Endothelial Dysfunction

Interventions: Drug: Placebo
Drug: Aliskiren

First Posted Date: 2010-02-11

Last Posted Date: 2013-02-13

Lead Sponsor: Mayo Clinic

Target Recruit Count: 22

Registration Number: NCT01067326

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Evaluation of Aliskiren Efficacy by Different Methods of Blood Pressure Measurements

Phase 4

Terminated

Conditions: Blood Pressure, High

Interventions: Drug: Aliskiren

First Posted Date: 2010-02-02

Last Posted Date: 2017-01-11

Lead Sponsor: Meir Medical Center

Target Recruit Count: 50

Registration Number: NCT01060865

Locations: 🇮🇱
Clalit health services, Hertsliyah, Hasharon Area, Israel

A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.

Phase 4

Completed

Conditions: High Blood Pressure

Interventions: Drug: Aliskiren and HCTZ

First Posted Date: 2010-01-26

Last Posted Date: 2017-02-23

Lead Sponsor: Novartis

Target Recruit Count: 253

Registration Number: NCT01056731

Locations: 🇻🇪
Investigative Site, Maracaibo Estado Zulia, Venezuela

Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

Phase 4

Completed

Conditions: Essential Hypertension

Interventions: Drug: Ramipril
Drug: Aliskiren
Drug: Matching placebo to Aliskiren
Drug: Matching placebo to Ramipril

First Posted Date: 2010-01-05

Last Posted Date: 2012-04-03

Lead Sponsor: Novartis

Target Recruit Count: 506

Registration Number: NCT01042392

Locations: 🇫🇷
Novartis Investigative Site, Witry-Les-Reims, France
🇫🇷
Novartis Investigator Site, Marsilly, France
🇫🇷
Investigative Site, Toulon, France

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