MedPath

Aliskiren

Generic Name
Aliskiren
Brand Names
Rasilez, Tekturna, Tekturna Hct
Drug Type
Small Molecule
Chemical Formula
C30H53N3O6
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

Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

Phase 4
Completed
Conditions
IgA Nephropathy
Interventions
First Posted Date
2009-06-17
Last Posted Date
2015-07-03
Lead Sponsor
The University of Hong Kong
Target Recruit Count
25
Registration Number
NCT00922311
Locations
🇨🇳

Department of Medicine, The University of Hong Kong, Hong Kong, China

🇨🇳

Queen Mary Hospital, Hong Kong, China

Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

Phase 3
Completed
Conditions
Acute Decompensated Heart Failure
Congestive Heart Failure
Interventions
Drug: Placebo
First Posted Date
2009-05-07
Last Posted Date
2013-11-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1639
Registration Number
NCT00894387
Locations
🇹🇷

Novartis Investigative Site, Talas / Kayseri, Turkey

Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment

Phase 2
Terminated
Conditions
Heart Failure
Kidney Failure
Interventions
Drug: Placebo
First Posted Date
2009-04-15
Last Posted Date
2013-05-17
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
41
Registration Number
NCT00881439
Locations
🇳🇱

University Medical Center Groningen, Groningen, Netherlands

Aliskiren for Immunoglobulin A (IgA) Nephropathy

Phase 3
Completed
Conditions
IgA Nephropathy
Interventions
Drug: Placebo
First Posted Date
2009-03-27
Last Posted Date
2012-12-04
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
22
Registration Number
NCT00870493
Locations
🇭🇰

Prince of Wales Hospital, Shatin, Hong Kong

Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal

First Posted Date
2009-03-19
Last Posted Date
2011-07-22
Lead Sponsor
Novartis
Target Recruit Count
822
Registration Number
NCT00865020
Locations
🇻🇪

Investigative Site, Caracas, Venezuela

🇭🇺

Invesitagtive Site, Budapest, Hungary

The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)

Phase 1
Completed
Conditions
Hypertension
Interventions
First Posted Date
2009-03-06
Last Posted Date
2016-01-22
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
12
Registration Number
NCT00856960

Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure

Phase 3
Completed
Conditions
Chronic Heart Failure
Interventions
First Posted Date
2009-03-02
Last Posted Date
2016-11-25
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
7064
Registration Number
NCT00853658
Locations
🇻🇪

Novartis Investigative Site, Maracaibo, Estado Zulia, Venezuela

Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

Phase 3
Completed
Conditions
Coronary Artery Disease (CAD)
Coronary Atherosclerosis
Interventions
Drug: Placebo
First Posted Date
2009-03-02
Last Posted Date
2014-06-03
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
613
Registration Number
NCT00853827
Locations
🇪🇸

Novartis Investigative Site, Madrid, Spain

A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

Phase 1
Completed
Conditions
Hypertension
Interventions
First Posted Date
2009-02-03
Last Posted Date
2011-05-09
Lead Sponsor
Novartis
Target Recruit Count
39
Registration Number
NCT00834041
Locations
🇵🇱

Investigative Site, Warsaw, Poland

Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise

First Posted Date
2009-01-09
Last Posted Date
2011-06-28
Lead Sponsor
Novartis
Target Recruit Count
68
Registration Number
NCT00819767
Locations
🇬🇧

Investigative Site, Leicester, United Kingdom

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