DeepMed Research

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

Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

Phase 3

Completed

Conditions: Essential Hypertension

Interventions: Drug: Aliskiren 150 mg
Drug: Amlodipine 2.5 mg
Drug: Aliskiren/Amlodipine 150/2.5 mg
Drug: Aliskiren/amlodipine 150/5 mg
Drug: Placebo of Amlodipine
Drug: Placebo of Aliskiren
Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg
Drug: Placebo of Aliskiren/amlodipine 150/5 mg

First Posted Date: 2010-11-09

Last Posted Date: 2012-06-13

Lead Sponsor: Novartis

Target Recruit Count: 1342

Registration Number: NCT01237223

Locations: 🇯🇵
Investigative Site, Tokyo, Japan

Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

Phase 4

Terminated

Conditions: Hypertension
Cardiac Transplantation

Interventions: Drug: Aliskiren

First Posted Date: 2010-11-07

Last Posted Date: 2018-06-29

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 1

Registration Number: NCT01235910

Locations: 🇺🇸
University of Colorado Denver, Aurora, Colorado, United States

Direct Renin Inhibition and the Kidney

Phase 1

Completed

Conditions: Renal Function

Interventions: Drug: VTP-27999
Drug: placebo
Drug: aliskiren

First Posted Date: 2010-10-08

Last Posted Date: 2016-02-29

Lead Sponsor: Vitae Pharmaceuticals, Inc.

Target Recruit Count: 22

Registration Number: NCT01217736

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

Phase 4

Conditions: Glomerulonephritis, IGA
Hypertension

First Posted Date: 2010-08-19

Last Posted Date: 2011-06-27

Lead Sponsor: Kagawa University

Target Recruit Count: 30

Registration Number: NCT01184599

Locations: 🇯🇵
Department of Internal Medicine, Osaka City General Hospital, Osaka, Japan
🇯🇵
Kurume University, School of Medicine, Fukuoka, Japan
🇯🇵
Kinki University, Faculty of Medicine, Osaka, Japan

and more 1 locations

ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

Phase 4

Completed

Conditions: Hypertension
Left Ventricle Hypertrophy

Interventions: Drug: Aliskiren
Drug: Losartan
Drug: Amlodipine
Drug: Hydrochlorothiazide (HCTZ)

First Posted Date: 2010-08-05

Last Posted Date: 2014-07-24

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 74

Registration Number: NCT01176032

Locations: 🇪🇸
Novartis Investigative Site, Santander, Spain

The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes

Not Applicable

Completed

Conditions: Diabetes Type 2

Interventions: Drug: Placebo
Drug: Aliskiren

First Posted Date: 2010-07-20

Last Posted Date: 2017-03-28

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 124

Registration Number: NCT01165983

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory, Boston, Massachusetts, United States

Significance of Regional Ventriculo-arterial Coupling in Patients With Chronic Heart Failure

Phase 4

Conditions: Heart Failure

Interventions: Drug: Aliskiren

First Posted Date: 2010-07-02

Last Posted Date: 2010-07-02

Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Target Recruit Count: 120

Registration Number: NCT01156207

Locations: 🇨🇳
Taipei Veterans General Hospital, Taipei, Taiwan
🇨🇳
National Taiwan University Hospital, Taipei, Taiwan

An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

Phase 3

Completed

Conditions: Hypertension

Interventions: Drug: Aliskiren
Drug: Enalapril

First Posted Date: 2010-06-28

Last Posted Date: 2016-03-07

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 208

Registration Number: NCT01151410

Locations: 🇹🇷
Novartis Investigative Site, Ankara, Turkey

Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

Phase 3

Completed

Conditions: Hypertension

Interventions: Drug: Aliskiren (6.25/12.5/25 mg)
Drug: Aliskiren (37.5/75/150 mg)
Drug: Aliskiren (150/300/600 mg)

First Posted Date: 2010-06-24

Last Posted Date: 2015-10-15

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 267

Registration Number: NCT01150357

Locations: 🇹🇷
Novartis Investigative Site, Izmir, Turkey

Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease

Phase 4

Completed

Conditions: Kidney Disease

Interventions: Drug: Aliskiren
Drug: Losartan

First Posted Date: 2010-06-24

Last Posted Date: 2015-07-03

Lead Sponsor: The University of Hong Kong

Target Recruit Count: 80

Registration Number: NCT01150201

Locations: 🇨🇳
Queen Mary Hospital, Hong Kong, China

Drug Development Updates

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