Clinical Trials

Candesartan cilexetil has been evaluated across numerous clinical trials, spanning Phase 1 pharmacokinetic evaluations to Phase 4 efficacy studies for various cardiovascular and renal indications. These trials cover conditions such as essential and pediatric hypertension, chronic heart failure, proteinuria, and chronic kidney disease, sponsored by major pharmaceutical companies and research institutes. Although many studies are completed, others display withdrawn, terminated, or unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05826912 ENROLLING_BY_INVITATION
Traumatic Brain Injury
University of California, San Francisco
 2024-08-01 PHASE2
NCT05920005 COMPLETED
Hypertension
Hospital Israelita Albert Einstein
 2023-08-22 PHASE3
NCT05122182 TERMINATED
COVID-19; SARS-CoV2 Infection
University of Sydney
 2022-01-07 PHASE2
NCT03847506 COMPLETED
Hypertension, Hyperlipidemia
HK inno.N Corporation
 2018-07-05 PHASE4
NCT02047019 WITHDRAWN
Hypertension
Bayer
 2017-12-01 PHASE3
NCT04012307 COMPLETED
Bioequivalence
Pharmtechnology LLC
 2019-07-11 PHASE1
NCT03231982 UNKNOWN
Hypertension
HK inno.N Corporation
 2017-04-17 PHASE4
NCT02521246 WITHDRAWN
Essential Arterial Hypertension
EMS
 2016-11 PHASE3
NCT02332824 COMPLETED
Type 2 Diabetes Mellitus and Microalbuminuria
Takeda
 2014-10-16 PHASE2
NCT02709187 COMPLETED
Healthy
Alvogen Korea
 2016-03 PHASE1
NCT02609711 UNKNOWN
Healthy Male Subjects
Ahn-Gook Pharmaceuticals Co.,Ltd
 2015-11 PHASE1
NCT02944734 COMPLETED
Essential Hypertension
Shin Poong Pharmaceutical Co. Ltd.
 2014-09 PHASE2
NCT02368652 COMPLETED
Essential Hypertension
HK inno.N Corporation
 2014-12 PHASE3
NCT02609711 Unknown status
Healthy Male Subjects
Ahn-Gook Pharmaceuticals Co.Ltd
 2015-11 Phase 1
NCT02368665 COMPLETED
Essential Hypertension
HK inno.N Corporation
 2014-12 PHASE3
NCT02548286 COMPLETED
Hypertension
Chong Kun Dang Pharmaceutical
 2015-08 PHASE1
NCT02059616 UNKNOWN
Essential Hypertension
HK inno.N Corporation
 2014-02 PHASE2
NCT02707224 COMPLETED
Healthy
Alvogen Korea
 2015-01 PHASE1
NCT02254447 COMPLETED
Cardiovascular Disease
GlaxoSmithKline
 2014-12-02 PHASE1
NCT02173912 UNKNOWN
Healthy Volunteers
HK inno.N Corporation
 2014-06 PHASE1
NCT02094924 COMPLETED
Hypertension
GlaxoSmithKline
 2014-04-17 PHASE1
NCT01788358 COMPLETED
Hypertension
Bayer
 2013-02-14 PHASE3
NCT02006589 COMPLETED
Hypertension
GlaxoSmithKline
 2013-12-11 PHASE1
NCT02006602 COMPLETED
Hypertension
GlaxoSmithKline
 2013-12-13 PHASE1
NCT01976572 COMPLETED
Hyperphosphatemia; Chronic Kidney Disease
Tanabe Pharma Corporation
 2013-10 PHASE1
NCT01926652 COMPLETED
Healthy
Shin Poong Pharmaceutical Co. Ltd.
 2013-07 PHASE1
NCT01845272 UNKNOWN
Healthy
HK inno.N Corporation
 2013-04 PHASE1
NCT01734096 COMPLETED
Hypertension; Obesity; White Coat Hypertension; Resistant Hypertension
PD Dr. Grégoire Wuerzner
 2009-05 PHASE4
NCT01611077 COMPLETED
Hypertension
Institut für Pharmakologie und Präventive Medizin
 2012-01 PHASE4
NCT01613209 COMPLETED
Hypertension
Institut für Pharmakologie und Präventive Medizin
 2011-12 PHASE3
NCT01303783 COMPLETED
Hypertension, Essential
Bayer
 2011-04 PHASE2
NCT01135212 COMPLETED
Hypertension
Boryung Pharmaceutical Co., Ltd
 2010-04 PHASE3
NCT01052272 COMPLETED
Diabetes
University of Alabama at Birmingham
 2005-07 PHASE2; PHASE3
NCT00120003 COMPLETED
Stroke
Ullevaal University Hospital
 2005-06 PHASE3
NCT03136666 COMPLETED
Clinical Pharmacology
Bayer
 2010-04-19 PHASE1
NCT01025843 COMPLETED
Hypertension
Merck Sharp & Dohme LLC
 2009-12-01 PHASE1
NCT01012479 COMPLETED
Hypertension
Takeda
 2009-10 PHASE4
NCT00679484 TERMINATED
Chronic Heart Failure; High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
 2008-06 PHASE3
NCT00984529 Completed
Chronic Heart Failure
AstraZeneca
 2009-09 --
NCT00690612 COMPLETED
Hypertension
AstraZeneca
 2007-09 PHASE3
NCT00573430 COMPLETED
Non-diabetic Nephropathy With Hypertension
AstraZeneca
 2007-12 PHASE4
NCT00184587 COMPLETED
Cluster Headache
Norwegian University of Science and Technology
 2005-03 PHASE2
NCT00844324 COMPLETED
Hypertension
AstraZeneca
 2009-03 PHASE1
NCT00139386 COMPLETED
Hypertension; Coronary Artery Disease
Kumamoto University
 2005-10 PHASE4
NCT00621153 COMPLETED
Stage II Hypertension
AstraZeneca
 2008-02 PHASE4
NCT00844324 Completed
Hypertension
AstraZeneca
 2009-03 Phase 1
NCT00905333 COMPLETED
Healthy
AstraZeneca
 2008-10 PHASE1
NCT00244621 COMPLETED
Hypertension
AstraZeneca
 2004-11 PHASE3
NCT00843154 TERMINATED
Heart Failure
Takeda
 2005-12 PHASE3
NCT01289132 COMPLETED
Essential Hypertension
Takeda
 2007-07 PHASE2
NCT00252733 COMPLETED
Type 1 Diabetes
AstraZeneca
 2001-06 PHASE3
NCT00252694 COMPLETED
Type 2 Diabetes
AstraZeneca
 2001-08 PHASE3
NCT00252720 COMPLETED
Type 1 Diabetes
AstraZeneca
 2001-08 PHASE3
NCT00434967 COMPLETED
Hypertension
AstraZeneca
 2007-01 PHASE3
NCT00383929 COMPLETED
Hypertension
AstraZeneca
 2006-09 PHASE3
NCT00227318 COMPLETED
Hypertension
AstraZeneca
 1998-07 PHASE3
NCT00244595 Completed
Hypertension
AstraZeneca
 2003-09 Phase 3
NCT00244634 Completed
Pediatric Hypertension
AstraZeneca
 2003-09 Phase 3
NCT00634712 COMPLETED
Congestive Heart Failure
AstraZeneca
 1999-06 PHASE3
NCT00634309 COMPLETED
Congestive Heart Failure
AstraZeneca
 1999-06 PHASE3
NCT00242346 Completed
Proteinuria
AstraZeneca
 2003-04 Phase 3
NCT00108706 UNKNOWN
Cerebrovascular Accident; Acute Stroke
City Hospitals Sunderland NHS Foundation Trust
 2004-12 PHASE4
NCT00242346 COMPLETED
Proteinuria
AstraZeneca
 2003-04 PHASE3
NCT00125463 UNKNOWN
Hypertension; Cardiovascular Diseases
The Japanese Society of Hypertension
 2001-09 PHASE3
NCT00244634 COMPLETED
Pediatric Hypertension
AstraZeneca
 2003-09 PHASE3
NCT00244595 COMPLETED
Hypertension
AstraZeneca
 2003-09 PHASE3
NCT00360763 UNKNOWN
Hypertension
Huazhong University of Science and Technology
 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-12-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Candesartan cilexetil acts as a prodrug that is hydrolyzed during gastrointestinal absorption into candesartan, a selective antagonist that binds to the angiotensin II receptor to block downstream vasoconstrictive signal transduction. This targeted receptor blockade prevents angiotensin II-mediated vascular smooth muscle contraction and aldosterone secretion, which directly correlates with its clinical efficacy in managing hypertension, chronic heart failure, and proteinuria.

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.