Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension

NCT05920005 ↗

Phase 3 Completed 702 enrolled Hospital Israelita Albert Einstein Libbs Farmacêutica LTDA · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the safety and efficacy of a new combination of 3 (three) antihypertensive drugs in a single pill (candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg) compared with another combination of 3 (three) antihypertensive drugs (Exforge HCT® \[valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg\]). This will be a non-inferiority trial and the primary outcome will be blood pressure control after 12 weeks of treatment.

Timeline

Start: 2023-08-22
Primary completion: 2025-03-31
Completion: 2025-05-01

Outcome

Met primary endpoint

paper systolic BP was -22.6 mm Hg in the experimental group vs -18.2 mm Hg in the control group PMID 40892621 ↗

paper between-group difference -4.4 mm Hg; 90% CI -6.3 to -2.5 mm Hg; P < 0.001 PMID 40892621 ↗

Publications

Madrini V Jr, Tavares CAM, Albuquerque MTA, Silvestre OM, Felicio JS, Silveira FS, Hissa MN, Antunes MO, Mota-Gomes MA, Vidotti MH, Fuchs FD, Marcondes-Braga FG, Filho CRH, Troiani do Nascimento C, Bastos RA, Brandao AA, Cestario EES, Bortolotto LA, Castilho VC, Lapa MG, Magaton EAP, Fernandes PB, Albuquerque CSN, Silva LR, Berwanger O, Guimaraes PO. Efficacy and Safety of a Novel Triple Single-Pill for Uncontrolled Hypertension: The OPTION TREAT Trial. JACC Adv. 2025 Oct;4(10 Pt 2):102175. doi: 10.1016/j.jacadv.2025.102175. Epub 2025 Aug 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Candesartan cilexetil	Unknown	16 mg	Oral
Subject	Chlorthalidone	Other / unclassified	12.5 mg	Oral
Comparator	Hydrochlorothiazide	Unknown	12.5 mg	Oral
Comparator	Valsartan	Unknown	160 mg	Oral
Comparator	Amlodipine	Other / unclassified	5 mg	Oral