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Aliskiren

Phase 1

Hypertension | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Jan 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Aliskiren · 1 trial · 1 indication

Phase 1 1
NCT00856960The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)Hypertension
COMPLETED12 Analytics
PHASE1COMPLETED
The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren
2-5 hours post dose of study drug

Secondary Endpoints

change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan
2-5 hours post dose of study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORAliskiren 600 mg
2ACTIVE_COMPARATORAliskiren 150 mg
3ACTIVE_COMPARATORLosartan 100 mg
4PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AliskirenDRUGSingle dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period.
Comparator: LosartanDRUGSingle dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period.
Comparator: Placebo to AliskirenDRUGThree or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period.
Comparator: Placebo to LosartanDRUGSingle dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is in generally good health * Subject is willing to avoid unaccustomed strenuous exercise during the study * Subject agrees to consume ONLY the study-specified diet during all domiciled periods * Subject has been a non-smoker for at least 3 months prior to study * Subj...

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Frequently asked questions about Aliskiren

What is Aliskiren used for?

Aliskiren is a small molecule drug being developed for the treatment of hypertension, a condition of high blood pressure. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being studied for its effects on renal blood flow in healthy male volunteers.

Who makes Aliskiren?

Aliskiren is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and effects in healthy volunteers with hypertension.

What phase is Aliskiren in?

Aliskiren is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and pharmacological effects. The drug is being studied in a small, early-stage trial.

What clinical trials is Aliskiren in?

Aliskiren has one completed clinical trial registered under NCT00856960, titled "The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)." This Phase 1 study enrolled 12 healthy male participants and was a randomized, double-blind, placebo-controlled trial.

Is Aliskiren FDA approved?

Aliskiren is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for hypertension. The drug has completed one early-stage trial, but it has not received regulatory approval and remains under investigation for its safety and efficacy.