Clinical Trials

Numerous clinical trials across Phase 1 through Phase 4 evaluate aliskiren for cardiovascular and renal conditions, including essential, stage 2, and arterial hypertension, heart failure, diabetic macular edema, Marfan syndrome, and renal function. Sponsored by pharmaceutical entities and academic institutions, these studies encompass recruitment statuses spanning completed, recruiting, terminated, withdrawn, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04183101 RECRUITING
C3 Glomerulopathy; Membranoproliferative Glomerulonephritis; Complement Abnormality; Dense Deposit Disease; C3 Glomerulonephritis
Region Skane
 2020-10-01 PHASE2
NCT06718062 COMPLETED
Hypertension,Essential; Hyperuricemia
Hansung University
 2021-05-01 PHASE4
NCT04432350 Withdrawn
COVID|Drug Effect|Drug Interaction|Risk Reduction
Tabula Rasa HealthCare
 2020-06-12 --
NCT01922141 WITHDRAWN
Hypertension
Novartis Pharmaceuticals
 2015-05 PHASE4
NCT00223717 COMPLETED
Hypertension
Vanderbilt University
 2001-01 PHASE1
NCT02909166 UNKNOWN
Atrial Fibrillation
Mika Lehto
 2012-01 PHASE3
NCT01893788 UNKNOWN
Hypertensive Left Ventricular Hypertrophy
Nagoya University
 2013-04 PHASE4
NCT01827202 COMPLETED
Hypertension; Chronic Kidney Disease; Proteinuria
Medical University of Vienna
 2012-12 PHASE4
NCT00853658 COMPLETED
Chronic Heart Failure
Novartis Pharmaceuticals
 2009-03 PHASE3
NCT01151410 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2010-08 PHASE3
NCT01519635 COMPLETED
Hypertension
Centre Hospitalier Universitaire Vaudois
 2011-10 PHASE4
NCT01715207 COMPLETED
Marfan Syndrome
Samsung Medical Center
 2010-06 PHASE3
NCT01150201 COMPLETED
Kidney Disease
The University of Hong Kong
 2009-07 PHASE4
NCT01461499 COMPLETED
Type 2 Diabetes Mellitus; Hypertension
Shiga University
 2011-10 PHASE4
NCT01150357 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2010-06 PHASE3
NCT02446548 COMPLETED
Albuminuria
Medical University of Gdansk
 2013-03
NCT01425242 TERMINATED
Hypertension; Abdominal Aortic Aneurysm
Amsterdam UMC, location VUmc
 2011-09
NCT01480791 WITHDRAWN
Hypertension; Diabetes
Sir Mortimer B. Davis - Jewish General Hospital
 2012-01 PHASE2
NCT01156207 UNKNOWN
Heart Failure
Taipei Veterans General Hospital, Taiwan
 2010-07 PHASE4
NCT01298258 UNKNOWN
Heart Failure
Taipei Veterans General Hospital, Taiwan
 2010-07
NCT01472796 UNKNOWN
Hypertension
Wayne State University
 2011-07 PHASE4
NCT01318395 COMPLETED
Arterial Hypertension
University of Erlangen-Nürnberg Medical School
 2010-05 PHASE3
NCT01409408 WITHDRAWN
Hypertension; Diabetes Mellitus
Hospital Universitario Pedro Ernesto
 2011-04 PHASE4
NCT01176032 COMPLETED
Hypertension; Left Ventricle Hypertrophy
Novartis Pharmaceuticals
 2010-06 PHASE4
NCT01184599 UNKNOWN
Glomerulonephritis, IGA; Hypertension
Kagawa University
 2010-06 PHASE4
NCT00549757 TERMINATED
Type 2 Diabetes Mellitus; Cardiovascular Disease
Novartis Pharmaceuticals
 2007-10 PHASE3
NCT00853827 COMPLETED
Coronary Artery Disease (CAD); Coronary Atherosclerosis
Novartis Pharmaceuticals
 2009-03 PHASE3
NCT01252238 TERMINATED
Insulin Sensitivity; Aortic Compliance; Diastolic Function
Brigham and Women's Hospital
 2010-06
NCT01235910 TERMINATED
Hypertension; Cardiac Transplantation
University of Colorado, Denver
 2011-05 PHASE4
NCT01432106 WITHDRAWN
Hypertension; Metabolic Syndrome
University of Michigan
 2011-02 PHASE1
NCT00994253 WITHDRAWN
Hypertension; Diabetes Type 2
Corewell Health East
 2009-08 PHASE4
NCT01570686 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2012-04 PHASE4
NCT01259297 TERMINATED
Cardiovascular Events
Novartis Pharmaceuticals
 2011-01 PHASE3
NCT01635387 UNKNOWN
Hypertension; End Stage Renal Disease
University of Campania Luigi Vanvitelli
 2010-02 PHASE4
NCT01394770 UNKNOWN
Hypertension; Dialysis
University of Campania Luigi Vanvitelli
 2009-09 PHASE4
NCT00894387 COMPLETED
Acute Decompensated Heart Failure; Congestive Heart Failure
Novartis Pharmaceuticals
 2009-05 PHASE3
NCT01103245 COMPLETED
Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders
Vanderbilt University Medical Center
 2010-03 PHASE1
NCT00961207 TERMINATED
Microalbuminuria; Macroalbuminuric Diabetic Nephropathy; Diabetes; Proteinuria; Albuminuria
Cook County Health
 2009-08 PHASE4
NCT00881439 TERMINATED
Heart Failure; Kidney Failure
University Medical Center Groningen
 2009-04 PHASE2
NCT01284114 COMPLETED
Hypertension; Chronic Kidney Disease
Jichi Medical University
 2011-02 PHASE4
NCT01570686 Completed
Hypertension
Novartis Pharmaceuticals|Novartis
 2012-04 Phase 4
NCT00498433 TERMINATED
Hypertension; Abdominal Obesity
Novartis
 2007-06 PHASE2
NCT00870493 COMPLETED
IgA Nephropathy
Chinese University of Hong Kong
 2009-04 PHASE3
NCT01237873 COMPLETED
Essential Hypertension
Novartis Pharmaceuticals
 2011-01 PHASE3
NCT01138423 COMPLETED
Hypertension; Abdominal Obesity; Metabolic Syndrome
UMC Utrecht
 2010-08 PHASE4
NCT01129557 TERMINATED
Proteinuric Kidney Disease; Diabetic Nephropathy; Hypertensive Nephrosclerosis; IgA Nephropathy; Focal Segmental Glomerulosclerosis; Glomerulopathy (Obesity-associated); Glomerulonephritis, Membranous
Columbia University
 2009-09 PHASE4
NCT01165983 COMPLETED
Diabetes Type 2
Beth Israel Deaconess Medical Center
 2009-11
NCT01349114 TERMINATED
Diabetes; Pre-hypertension; Hypertension
University of Alabama at Birmingham
 2011-06 PHASE4
NCT03115853 COMPLETED
High Blood Pressure
Vanderbilt University Medical Center
 2009-06 PHASE4
NCT01437943 TERMINATED
Kidney Disease; Kidney Failure, Chronic
Brigham and Women's Hospital
 2010-04 PHASE4
NCT01067326 TERMINATED
Endothelial Dysfunction
Mayo Clinic
 2010-02 PHASE3
NCT01302899 TERMINATED
Non-diabetic Nephropathy
Novartis Pharmaceuticals
 2011-01 PHASE2
NCT01093781 WITHDRAWN
Idiopathic Membranous Nephropathy
Mayo Clinic
 2010-11
NCT01417104 TERMINATED
Atherosclerosis
Ohio State University
 2009-10 PHASE2; PHASE3
NCT00974922 TERMINATED
Vitamin D Deficiency; Hypertension
UConn Health
 2009-08 PHASE4
NCT01217736 COMPLETED
Renal Function
Vitae Pharmaceuticals, Inc.
 2010-09 PHASE1
NCT01060865 TERMINATED
Blood Pressure, High
Meir Medical Center
 2010-03 PHASE4
NCT00935064 COMPLETED
Diabetes
Christiana Care Health Services
 2009-06
NCT00927394 COMPLETED
Hypertension
Novartis
 2009-05 PHASE4
NCT01056731 COMPLETED
High Blood Pressure
Novartis
 2010-02 PHASE4
NCT01519635 Completed
Hypertension
Centre Hospitalier Universitaire Vaudois
 2011-10 Phase 4
NCT00982033 COMPLETED
Heart Failure
Wake Forest University Health Sciences
 2009-07 PHASE4
NCT01305850 UNKNOWN
Peritoneal Membrane Failure
Chulalongkorn University
 2010-07 PHASE4
NCT00818779 COMPLETED
Coronary Artery Disease; Type 2 Diabetes Mellitus
Texas Tech University Health Sciences Center
 2008-01 PHASE4
NCT01125514 COMPLETED
Heart Failure
Novartis Pharmaceuticals
 2010-05 PHASE2
NCT01541267 COMPLETED
Chronic Kidney Disease; Proteinuria
Medical University of Gdansk
 2009-12 PHASE4
NCT01237223 COMPLETED
Essential Hypertension
Novartis
 2010-10 PHASE3
NCT01235910 Terminated
Hypertension|Cardiac Transplantation
University of Colorado Denver|American Heart Association
 2011-05 Phase 4
NCT00768040 TERMINATED
Diabetic Macular Edema
Novartis Pharmaceuticals
 2008-09 PHASE2
NCT00923156 COMPLETED
Heart Failure
Novartis Pharmaceuticals
 2009-05 PHASE2
NCT01042392 COMPLETED
Essential Hypertension
Novartis
 2009-11 PHASE4
NCT01095822 UNKNOWN
Diabetes Mellitus
HeartDrug Research LLC
 2010-03 PHASE4
NCT00922311 COMPLETED
IgA Nephropathy
The University of Hong Kong
 2009-07 PHASE4
NCT01080768 TERMINATED
Hypertension; Ankle Edema
Novartis Pharmaceuticals
 2010-02 PHASE2
NCT00797862 COMPLETED
Hypertension
Novartis
 2008-11 PHASE3
NCT01070030 COMPLETED
Stage II Hypertension
Novartis
 2010-01 PHASE4
NCT01113047 COMPLETED
Essential Hypertension
Novartis
 2010-05 PHASE3
NCT01568775 COMPLETED
End Stage Renal Disease
Novartis
 2010-06 PHASE1
NCT01040494 UNKNOWN
Congestive Heart Failure
National Taiwan University Hospital
 2010-01 PHASE4
NCT01219413 COMPLETED
Chronic Kidney Disease; Proteinuria; Blood Pressure
Medical University of Gdansk
 2009-03 PHASE4
NCT00949351 UNKNOWN
Type 2 Diabetes With Nephropathy
Lerdsin General Hospital
 2009-09 PHASE4
NCT00417170 COMPLETED
High Blood Pressure; Metabolic Syndrome; Insulin Resistance; Endothelial Dysfunction
Novartis Pharmaceuticals
 2007-10 PHASE2
NCT00865020 COMPLETED
Hypertension
Novartis
 2009-03 PHASE4
NCT00627861 TERMINATED
Hypertension
The Rogosin Institute
 2008-11
NCT00856960 COMPLETED
Hypertension
Merck Sharp & Dohme LLC
 2010-01 PHASE1
NCT01038895 UNKNOWN
Hypertension; Type 2 Diabetes
University of Pavia
 2009-11 PHASE4
NCT00942994 COMPLETED
Hypertension
Novartis
 2009-06 PHASE4
NCT00787605 COMPLETED
Hypertension; Diabetes Mellitus
Novartis
 2008-11 PHASE4
NCT00834041 COMPLETED
Hypertension
Novartis
 2009-04 PHASE1; PHASE2
NCT00939588 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2009-07 PHASE2
NCT00797316 COMPLETED
Hypertension
Novartis
 2008-11 PHASE4
NCT00933920 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2009-06 PHASE1
NCT00660309 COMPLETED
Type 2 Diabetes Mellitus
Novartis
 2008-04 PHASE4
NCT01048047 UNKNOWN
Hypertension
University of Pavia
 2009-11 PHASE4
NCT00667719 COMPLETED
Essential Hypertension
Novartis
 2008-06-05 PHASE3
NCT00819767 COMPLETED
Hypertension
Novartis
 2009-02 PHASE2
NCT00631917 COMPLETED
Hypertension
Novartis
 2008-02 PHASE4
NCT00732407 UNKNOWN
Diabetes Mellitus; Atherosclerosis
Assaf-Harofeh Medical Center
 2008-09
NCT00414609 COMPLETED
Myocardial Infarction
Novartis
 2006-12 PHASE3
NCT00841672 COMPLETED
Moderate to Severe Hypertension
Novartis
 2009-01 PHASE3
NCT00867490 COMPLETED
Hypertension
Novartis
 2009-03 PHASE3
NCT00765674 COMPLETED
Hypertension
Novartis
 2008-09 PHASE3
NCT00765947 COMPLETED
Essential Hypertension ( Mild to Moderate)
Novartis
 2008-09 PHASE4
NCT00773084 WITHDRAWN
Diastolic Heart Failure
Texas Tech University Health Sciences Center
 2008-09
NCT00853957 COMPLETED
Hypertension
Novartis
 2009-02 PHASE4
NCT00809926 COMPLETED
Stage 2 Hypertension
Novartis
 2009-01 PHASE4
NCT00719316 UNKNOWN
Chronic Kidney Disease; Hypertension; Muscle Sympathetic Nerve Activity
UMC Utrecht
 2008-07 PHASE4
NCT00542269 TERMINATED
Hypertension With Metabolic Syndrome
Novartis
 2008-03 PHASE4
NCT00778921 COMPLETED
Hypertension
Novartis
 2008-10 PHASE3
NCT00777946 COMPLETED
Hypertension
Novartis
 2008-10 PHASE3
NCT00739973 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2008-09 PHASE3
NCT00760266 COMPLETED
Hypertension
Novartis
 2008-09 PHASE4
NCT00706134 COMPLETED
Hypertension
Novartis
 2008-05 PHASE3
NCT00409578 COMPLETED
Post Acute Coronary Syndrome; Myocardial Ischemia
Novartis
 2007-02 PHASE2
NCT00705575 COMPLETED
Hypertension
Novartis
 2008-06 PHASE3
NCT00739596 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2008-07 PHASE4
NCT00772577 COMPLETED
Hypertension
Novartis
 2008-08 PHASE4
NCT00654875 COMPLETED
Essential Hypertension
Novartis
 2008-03 PHASE4
NCT00386607 COMPLETED
Hypertension
Novartis
 2006-10 PHASE3
NCT00529451 COMPLETED
Hypertension
Novartis
 2007-09 PHASE3
NCT00464776 COMPLETED
Diabetes Mellitus, Type 2
Novartis
 2005-10 PHASE1; PHASE2
NCT00402103 COMPLETED
Hypertension
Novartis
 2006-11 PHASE3
NCT00368277 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2006-09 PHASE3
NCT00441064 COMPLETED
Hypertension
Novartis
 2007-01 PHASE4
NCT00219141 COMPLETED
Hypertension; Left Ventricular Hypertrophy; Overweight
Novartis Pharmaceuticals
 2005-10 PHASE3
NCT00387517 COMPLETED
Hypertension
Novartis
 2006-10 PHASE3
NCT00518765 COMPLETED
Hypertension
Novartis
 2005-10 PHASE3
NCT00386139 COMPLETED
Hypertension
Novartis
 2006-09 PHASE3
NCT00299832 COMPLETED
Hypertension
Novartis
 2006-04 PHASE3
NCT00219102 COMPLETED
Hypertension; Diabetes
Novartis
 2005-06 PHASE3
NCT00344110 COMPLETED
Hypertension
Novartis
 2006-06 PHASE3
NCT00097955 COMPLETED
Diabetic Nephropathy
Novartis Pharmaceuticals
 2004-10 PHASE2
NCT00219011 COMPLETED
Heart Failure
Novartis
 2005-05 PHASE3
NCT00219193 COMPLETED
Hypertension
Novartis
 2005-10 PHASE3
NCT00343551 COMPLETED
Essential Hypertension
Novartis
 2006-05 PHASE3
NCT00461136 COMPLETED
Diabetes Type 2
Novartis
 2005-08 PHASE1; PHASE2
NCT00299806 COMPLETED
Hypertension
Novartis
 2006-04 PHASE3
NCT00260923 COMPLETED
Hypertension
Novartis
 2005-11 PHASE3
NCT00219180 COMPLETED
Hypertension
Novartis
 2005-06 PHASE3
NCT00262236 COMPLETED
Hypertension
Novartis
 2005-11 PHASE3
NCT00294710 COMPLETED
Hypertension
Novartis
 2005-03 PHASE3
NCT00219115 COMPLETED
Hypertension
Novartis
 2005-01 PHASE3
NCT00219063 COMPLETED
Hypertension
Novartis
 2005-02 PHASE3
NCT00171405 COMPLETED
Hypertension
Novartis
 2005-06 PHASE3
NCT00219167 COMPLETED
Hypertension
Novartis
 2005-04 PHASE3
NCT00219154 COMPLETED
Hypertension
Novartis
 2005-03 PHASE3
NCT00219050 COMPLETED
Hypertension
Novartis
 2005-02 PHASE3
NCT00219037 COMPLETED
Hypertension
Novartis
 2004-06 PHASE3
NCT00219076 COMPLETED
Hypertension
Novartis
 2005-02 PHASE3
NCT00219089 COMPLETED
Hypertension, Diabetes Mellitus
Novartis
 2004-11 PHASE3
NCT00219128 COMPLETED
Hypertension
Novartis
 2004-11 PHASE3
NCT00219024 COMPLETED
Hypertension
Novartis
 2004-08 PHASE3
NCT00311012 COMPLETED
Hypertension
Novartis
 2004-08 PHASE2
NCT00424541 COMPLETED
Hypertension
Novartis
 2007-01 PHASE1
NCT00416468 COMPLETED
Healthy
Novartis
 2006-11 PHASE1
NCT00416728 COMPLETED
Healthy
Novartis
 2006-11 PHASE1
NCT00464880 COMPLETED
Diabetes Type 2
Novartis
 2005-09 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-06-22)

Check the Aliskiren product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aliskiren is a potent, direct renin inhibitor that selectively binds to the catalytic site of human renin, thereby inhibiting the cleavage of angiotensinogen into angiotensin I and suppressing downstream angiotensin II production. This inhibition prevents systemic vasoconstriction and aldosterone release, which directly contributes to blood pressure reduction and vascular protection in clinical contexts such as hypertension, heart failure, and renal impairment.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.