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
Associated Therapies
-

Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.

Phase 3
Completed
Conditions
First Posted Date
2006-06-23
Last Posted Date
2017-02-23
Lead Sponsor
Novartis
Target Recruit Count
654
Registration Number
NCT00343551
Locations
🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

SPP100 Dose Finding Study in Japan

Phase 2
Completed
Conditions
First Posted Date
2006-04-05
Last Posted Date
2011-11-08
Lead Sponsor
Novartis
Target Recruit Count
445
Registration Number
NCT00311012
Locations
🇯🇵

Novartis Pharmaceuticals, Tokyo, Japan

SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Phase 3
Completed
Conditions
First Posted Date
2006-03-07
Last Posted Date
2016-11-18
Lead Sponsor
Novartis
Target Recruit Count
40
Registration Number
NCT00299832
Locations
🇯🇵

Novartis Pharmaceuticals, Japan, Japan

SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Phase 3
Completed
Conditions
First Posted Date
2006-03-07
Last Posted Date
2016-11-18
Lead Sponsor
Novartis
Target Recruit Count
39
Registration Number
NCT00299806
Locations
🇯🇵

Novartis Pharmaceuticals, Japan, Japan

A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine

Phase 3
Completed
Conditions
First Posted Date
2006-02-22
Last Posted Date
2011-11-08
Lead Sponsor
Novartis
Target Recruit Count
976
Registration Number
NCT00294710
Locations
🇺🇸

Novartis, East Hanover, New Jersey, United States

Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension

Phase 3
Completed
Conditions
First Posted Date
2005-12-06
Last Posted Date
2016-11-18
Lead Sponsor
Novartis
Target Recruit Count
693
Registration Number
NCT00262236
Locations
🇨🇭

Novartis, Basel, Switzerland

A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

Phase 3
Completed
Conditions
First Posted Date
2005-12-02
Last Posted Date
2011-11-08
Lead Sponsor
Novartis
Target Recruit Count
641
Registration Number
NCT00260923
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

Phase 3
Completed
Conditions
First Posted Date
2005-09-22
Last Posted Date
2020-02-11
Lead Sponsor
Novartis
Target Recruit Count
336
Registration Number
NCT00219102
Locations
🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

🇺🇦

Investigative Site, Kiev, Ukraine

A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

Phase 3
Completed
Conditions
First Posted Date
2005-09-22
Last Posted Date
2016-11-18
Lead Sponsor
Novartis
Target Recruit Count
355
Registration Number
NCT00219167
Locations
🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure

Phase 3
Completed
Conditions
First Posted Date
2005-09-22
Last Posted Date
2017-05-17
Lead Sponsor
Novartis
Target Recruit Count
1797
Registration Number
NCT00219180
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

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