azilsartan medoxomil: Clinical Trials

25 completed, 2 terminated, 1 not yet recruiting. 20 Phase 3, 3 Phase 1, 1 Phase 2, 1 Phase 4.

By phase and status

Phase	Trials	Status
Phase 3	20	Completed 19, Terminated 1
Phase 1	3	Completed 1, Not yet recruiting 1, Terminated 1
Phase 2	1	Completed 1
Phase 4	1	Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC Nizhpharm, Russia) Azilsartan medoxomil 80 mg tablet, Edarbi® 80 mg tablets - Hypertension	Phase 1	Not yet recruiting	Gedeon Richter Plc.	56	2025-06-06	2025-05-25
Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus. Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi] - Arterial Hypertension, Diabetes Mellitus		Completed	Research Institute for Complex Problems of Cardiovascular Diseases, Russia	184	2018-11-07	2022-10-26
A Study for PMS of AZL-M in the Treatment of Adult Participants With Essential Hypertension in South Korea Azilsartan Medoxomil - Essential Hypertension		Completed	Celltrion Pharm, Inc.	3438	2018-08-07	2023-10-26
International Multicenter, Observational, Non-Interventional Prospective Study of Azilsartan Medoxomil in Participants With Arterial Hypertension Who Are Overweight or Obese in the Russian Federation and The Republic of Kazakhstan Azilsartan Medoxomil - Hypertension		Completed	Takeda	1945	2016-07-18	2019-11-20
A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants TAK-491, TAK-491 placebo - Healthy Volunteer	Phase 1	Completed	Takeda	64	2015-11-20	2020-02-05
Azilsartan Medoxomil (TAK-491) Compared to Valsartan in Chinese Participants With Hypertension Azilsartan medoxomil, Valsartan, Azilsartan medoxomil Placebo - Essential Hypertension	Phase 3	Completed	Takeda	612	2015-08-27	2019-03-05
Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia Azilsartan Medoxomil - Essential Hypertension, Type 2 Diabetes Mellitus	Phase 4	Completed	Takeda	380	2015-07-13	2019-03-01
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension Azilsartan Medoxomil Low-dose, Losartan, Placebo for Azilsartan Medoxomil - Hypertension	Phase 3	Completed	Arbor Pharmaceuticals, Inc.	377	2015-03-30	2025-02-25
Azilsartan Medoxomil (TAK-491) Compared to Placebo in Korean Adults With Hypertension Azilsartan medoxomil, Azilsartan medoxomil placebo - Hypertension	Phase 3	Completed	Takeda	328	2014-07-01	2016-12-19
Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes Placebo, Azilsartan medoxomil - Hypertension, Diabetes	Phase 3	Terminated	Takeda	105	2012-01-01	2015-05-06
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone Azilsartan medoxomil/placebo, Azilsartan medoxomil - chlorthalidone - Essential Hypertension	Phase 3	Completed	Takeda	507	2011-10-01	2014-04-23
Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide - Safety	Phase 3	Completed	Takeda	153	2011-03-01	2013-12-13
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults Azilsartan medoxomil (TAK-491) - Hypertension	Phase 1	Terminated	Takeda	29	2010-05-01	2014-07-25
Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension. Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide - Essential Hypertension	Phase 3	Completed	Takeda	1071	2010-01-01	2012-02-07
Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide - Essential Hypertension	Phase 3	Completed	Takeda	837	2009-10-01	2012-11-12
Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil-hydrochlorothiazide - Essential Hypertension	Phase 3	Completed	Takeda	1085	2009-03-01	2012-03-13
Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone in Participants With Moderate to Severe Hypertension Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and hydrochlorothiazide - Essential Hypertension	Phase 3	Completed	Takeda	609	2009-02-01	2012-02-07
Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension Azilsartan medoxomil and chlorthalidone, Chlorthalidone, Azilsartan medoxomil - Hypertension	Phase 3	Completed	Takeda	1711	2009-01-01	2012-02-07
An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension. Azilsartan medoxomil, Valsartan, Olmesartan - Hypertension	Phase 3	Completed	Takeda	1291	2008-04-01	2011-04-19
Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential Hypertension Azilsartan medoxomil, Ramipril - Hypertension	Phase 3	Completed	Takeda	885	2008-01-01	2012-11-15

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Conditions studied

Hypertension (24)  ·  Essential Hypertension (14)  ·  Cardiovascular Diseases (10)  ·  Vascular Diseases (6)  ·  Diabetes Mellitus (2)  ·  Angina, Stable (1)  ·  Diabetes Mellitus, Type 2 (1)  ·  Kidney Diseases (1)  ·  Renal Insufficiency (1)

Sponsors

Takeda (24)  ·  Arbor Pharmaceuticals, Inc. (1)  ·  Celltrion Pharm, Inc. (1)  ·  Gedeon Richter Plc. (1)  ·  Research Institute for Complex Problems of Cardiovascular Diseases, Russia (1)

Countries

United States (16)  ·  Mexico (9)  ·  Russia (6)  ·  Argentina (5)  ·  Poland (5)  ·  Bulgaria (4)  ·  Chile (4)  ·  Germany (4)  ·  Netherlands (4)  ·  Peru (4)  ·  China (3)  ·  Slovakia (3)  ·  United Kingdom (3)  ·  Brazil (2)  ·  Estonia (2)

Top investigators

Steve Caras, MD (1)

Results publications

PMID 21282560, PMID 21272195, PMID 21762358, PMID 22710649, PMID 22939358, PMID 25619410, PMID 29334491, PMID 29445520, PMID 29504252, PMID 30175930, PMID 32769878

NIH funding

2008 (2), 2009 (1)