Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920005
Status:
RECRUITING
Last Update Posted:
2023-08-24
First Post:
2023-06-16
Brief Title:
Candesartan Cilexetil Chlorthalidone Amlodipine Versus Exforge HCT for Systemic Arterial Hypertension
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
A Multicenter Double-blind Controlled Randomized Trial to Evaluate the Association Candesartan Cilexetil Chlorthalidone Amlodipine Versus Exforge HCT for Systemic Arterial Hypertension
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTION TREAT
Brief 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 125mg amlodipine 5mg compared with another combination of 3 three antihypertensive drugs Exforge HCT valsartan 160mg hydrochlorothiazide 125mg amlodipine 5mg This will be a non-inferiority trial and the primary outcome will be blood pressure control after 12 weeks of treatment
Detailed Description:
This phase III multicenter randomized double-blind controlled parallel trial will evaluate the non-inferiority of the association between candesartan cilexetil 16mg chlorthalidone 125mg amlodipine 5mg in relation to Exforge HCT valsartan 160mg hydrochlorothiazide 12 5mg amlodipine 5mg in the treatment of systemic arterial hypertension A total of 698 participants will be included Follow-up visits will occur four eight and twelve weeks after the date of the randomization visit A telephone contact will be performed 30 days after the end of treatment The primary efficacy outcome is the mean change in blood pressure measured at the research site 12 weeks after starting treatment compared to baseline Incidence of adverse events will be collected from the first dose of treatment up to 30 days after the end of the treatment foreseen in the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None