Benicar (olmesartan medoxomil) / Daiichi Sankyo - LARVOL DELTA

Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: EMS | N=261 ➔ 0 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jun 2026 ➔ Jun 2025

Enrollment change • Trial primary completion date • Trial withdrawal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: EMS | N=348 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

ATHESA: Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension (clinicaltrials.gov) - P3 | N=352 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A.

New P3 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control (clinicaltrials.gov) - P3 | N=348 | Not yet recruiting | Sponsor: EMS | Trial completion date: Sep 2024 ➔ Sep 2026 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control (clinicaltrials.gov) - P3 | N=261 | Not yet recruiting | Sponsor: EMS | Trial completion date: Nov 2024 ➔ Nov 2026 | Trial primary completion date: Jun 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

Angiotensin Receptor Blocker-Related Sprue-like Enteropathy: Review of Food and Drug Administration Adverse Event Reporting System. (PubMed, Ann Pharmacother) - "Of these, 4240 cases (98.0%) of ARB-related SE were reported in patients using products with olmesartan, and 97 cases of SE were reported for all other ARBs (eprosartan, losartan, telmisartan, irbesartan, valsartan, and candesartan). There was a steep decline in reports of olmesartan-related SE following the lawsuit with potential of lawyer interference. There are reports of SE related to ARBs other than olmesartan, with increased physician awareness and the potential to discover a class effect with future studies."

Adverse events • Journal • Review • Cardiovascular • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Hypertension

ARBs CORONA II: Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection? (clinicaltrials.gov) - P3 | N=341 | Terminated | Sponsor: University of British Columbia | N=1372 ➔ 341 | Trial completion date: Jun 2021 ➔ Apr 2022 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2021 ➔ Apr 2022; DSMC recommendation due to futility

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control (clinicaltrials.gov) - P3 | N=261 | Not yet recruiting | Sponsor: EMS | Trial completion date: Nov 2022 ➔ Nov 2024 | Trial primary completion date: Jun 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control (clinicaltrials.gov) - P3 | N=348 | Not yet recruiting | Sponsor: EMS | Trial completion date: Sep 2022 ➔ Sep 2024 | Trial primary completion date: Jun 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

CASES OF SPRUE-LIKE ENTEROPATHY RELATED TO ANGIOTENSIN RECEPTOR BLOCKERS: A REVIEW OF THE FOOD AND DRUG ADMINISTRATION ADVERSE EVENT REPORTING SYSTEM (FAERS) (DDW 2022) - "357 cases of SE were reported combined for other ARBs (Eprosartan, losartan, telmisartan, irbesartan, valsartan). This suggests that ARB-related SE may be specific to Benicar and not a drug class effect. The marked decline in reports for ARB-related SE in the past two years is under investigation."

Adverse events • Clinical • Review • Celiac Disease • Gastrointestinal Disorder

"#CHCNewsflash: Stem & Root, an all-natural product line developed by @Bayer #Bayer and #NutriLeads, has announced the launch of Daily #Immunity featuring the award-winning ingredient #BeniCaros" (@NicholasHallCo)

A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia (clinicaltrials.gov) - P3; N=265; Completed; Sponsor: Daewoong Pharmaceutical Co. LTD.; Recruiting ➔ Completed; N=102 ➔ 265

Clinical • Enrollment change • Trial completion • Dyslipidemia • Hypertension

"Dammit. Now this is in my head forever. Similar to the way I sing olmesartan Benicar to the melody of old MacDonald" (@Ticagrelauren)

Antihypertensive Effects of Gynura divaricata (L.) DC in Rats with Renovascular Hypertension. (PubMed, Nutrients) - "Furthermore, the acetylcholine-, sodium nitroprusside-, and atrial natriuretic peptide-mediated reduction of vasodilation in 2K1C rat aortic rings was also ameliorated by GD treatment (GD 200 mg/kg/day; p < 0.01, p < 0.05, and p < 0.05 vs. 2K1C for vasodilation percentage in case of each compound). These findings indicate that GD shows beneficial effects against high blood pressure by modulating the RAAS in the cardio-renal syndrome. Thus, it should be considered an effective traditional medicine in hypertension treatment."

Journal • Cardiovascular • Diabetes • Fibrosis • Hypertension • Immunology • Metabolic Disorders • Nephrology • Renal Disease

"There's always Benicar (olmesartan) for that popcorn smell but unfortunately not ID related." (@blandman19)

"En CS Benicarló (Castellón-Spain), #NuncaAprenderemos" (@vic_pallares)

Fimasartan Achieving SBP Target (FAST) Study (clinicaltrials.gov) - P4; N=360; Recruiting; Sponsor: Boryung Pharmaceutical Co., Ltd; Enrolling by invitation ➔ Recruiting; Trial primary completion date: Dec 2016 ➔ Jun 2017

Enrollment status • Trial primary completion date • Biosimilar • Cardiovascular

Structural Basis for Ligand Recognition and Functional Selectivity at Angiotensin Receptor. (PubMed) - "Using docking simulations and site-directed mutagenesis we identified specific interactions between AT1R and different ARBs, including olmesartan derivatives with inverse agonist, neutral antagonist or agonist activities. We further observed that the mutation Asn1113.35Ala in the putative sodium-binding site affects binding of the endogenous peptide agonist Angiotensin II, but not the β-arrestin-biased peptide TRV120027."

Journal • Biosimilar

Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control (clinicaltrials.gov) - P3; N=348; Not yet recruiting; Sponsor: EMS; Trial completion date: Sep 2019 ➔ Sep 2022; Trial primary completion date: Jun 2019 ➔ Jun 2022

Trial completion date • Trial primary completion date

Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control (clinicaltrials.gov) - P3; N=261; Not yet recruiting; Sponsor: EMS; Trial completion date: Nov 2019 ➔ Nov 2022; Trial primary completion date: Jun 2019 ➔ Jun 2022

Trial completion date • Trial primary completion date

In vitro and in vivo evaluation of Olmesartan Medoxomil microcrystals and nanocrystals: Preparation, characterization, and pharmacokinetic comparison in Beagle Dogs. (PubMed, Curr Drug Deliv) - "Particles size reduction to nano-scale by means of nanocrystals technology significantly increased in vitro dissolution rate and in vivo oral bioavailability of OLM."

Journal • PK/PD data • Preclinical

A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Pharmtechnology LLC; Not yet recruiting ➔ Recruiting

Enrollment open

A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions (clinicaltrials.gov) - P1; N=32; Not yet recruiting; Sponsor: Pharmtechnology LLC

Clinical • New P1 trial

Cases of Angiotensin Receptor Blocker (ARB) Related Sprue-Like Enteropathy (SE): A Review of the Food and Drug Administration Adverse Event Reporting System (FAERS) (ACG 2019) - "A total of 77,245 FAERS reports of people for ARBs were analyzed. SE was identified in 5,290 (6.8%) cases. With the exception of 6 cases, all were related to olmesartan."

Adverse events • Clinical

The Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil After a Single Oral Dose Administration Under Fasting Conditions. (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Pharmtechnology LLC; Recruiting ➔ Completed

Clinical • Trial completion