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

A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension

Phase 3
Completed
Conditions
Hypertension
First Posted Date
2005-09-22
Last Posted Date
2011-02-25
Lead Sponsor
Novartis
Target Recruit Count
180
Registration Number
NCT00219050
Locations
🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

🇪🇸

Investigative Site, Madrid, Spain

A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

Phase 3
Completed
Conditions
Hypertension, Diabetes Mellitus
First Posted Date
2005-09-22
Last Posted Date
2017-05-17
Lead Sponsor
Novartis
Target Recruit Count
839
Registration Number
NCT00219089
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients

Phase 3
Completed
Conditions
Hypertension
First Posted Date
2005-09-22
Last Posted Date
2017-05-18
Lead Sponsor
Novartis
Target Recruit Count
504
Registration Number
NCT00219076
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

Phase 3
Completed
Conditions
Hypertension
First Posted Date
2005-09-22
Last Posted Date
2017-05-17
Lead Sponsor
Novartis
Target Recruit Count
844
Registration Number
NCT00219063
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

Phase 3
Completed
Conditions
Hypertension
First Posted Date
2005-09-22
Last Posted Date
2017-02-07
Lead Sponsor
Novartis
Target Recruit Count
641
Registration Number
NCT00219193
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

Phase 3
Completed
Conditions
Hypertension
First Posted Date
2005-09-15
Last Posted Date
2016-11-18
Lead Sponsor
Novartis
Target Recruit Count
250
Registration Number
NCT00171405
Locations
🇬🇧

Investigative Site, London, United Kingdom

Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria

Phase 2
Completed
Conditions
Diabetic Nephropathy
First Posted Date
2004-12-02
Last Posted Date
2017-05-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
496
Registration Number
NCT00097955
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

🇬🇧

Investigative Site, London, United Kingdom

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