Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608472
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Randomized Double-blind Double-dummy Active-controlled Multicenter Efficacy and Safety Study of a New Fixed-dose Combination of an Angiotensin Receptor Blocker and a Thiazide Diuretic for the Treatment of Essential Primary Arterial Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHESA
Brief Summary:
This is a phase III non-inferiority randomized double-blind double-dummy active-controlled multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy on systolic blood pressure SBP in the sitting position in the medical office in patients with SAH after 8 weeks of treatment
Detailed Description:
This is a phase III non-inferiority randomized double-blind double-dummy active-controlled multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy olmesartan 40 mg hydrochlorothiazide 25 mg in individuals with stage 2 primary arterial hypertension SBP 160 179 mm Hg or DBP 100 109 mm Hg This study will be used to support the registration of the new FDC of Eurofarma Laboratórios SA
The randomized treatment period aims to demonstrate the non-inferiority of the new combination compared to its comparator on the SBP in patients with SAH in 8 weeks of treatment after randomization
Throughout the study the participant must attend to six 06 in-person visits to the research site being two Screening Visits VSV1 and V2 throughout the run-in period one Randomization Visit VRV3 one follow-up visit after four 04 weeks V4 one visit for ABPM placement after seven 07 weeks V5 and one Final Visit VFV6 after eight 08 weeks of randomized treatment this being the visit to assess the primary endpoint of the study
The randomized treatment period aims to demonstrate the non-inferiority of the new combination compared to its comparator on the SBP in patients with SAH in 8 weeks of treatment after randomization
Throughout the study the participant must attend to six 06 in-person visits to the research site being two Screening Visits VSV1 and V2 throughout the run-in period one Randomization Visit VRV3 one follow-up visit after four 04 weeks V4 one visit for ABPM placement after seven 07 weeks V5 and one Final Visit VFV6 after eight 08 weeks of randomized treatment this being the visit to assess the primary endpoint of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None