Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647745
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
A Randomized Double-blind Multi-center Active-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of THP-00101 THP-00102 and THP-00103 in Subjects With T2DM and Essential Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Multi-center Active-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of THP-00101 THP-00102 and THP-00103 in Subjects With T2DM and Essential Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
THP-001-031
Brief Summary:
Primary Objective To demonstrate the superiority of the change in mean sitting systolic blood pressure MSSBP and hemoglobin A1c HbA1con week 12 of the combination therapy of THP-00101 dapagliflozin 10 mg and THP-00102 telmisartan 80 mg compared to THP-00101 or THP-00102 monotherapy among subjects with type 2 diabetes mellitus accompanied by essential hypertension Secondary Objective To comparatively evaluate secondary efficacy and safety in the THP-00101 monotherapy group THP-00102 monotherapy group THP-00101 and THP-00102 combination therapy group and THP-00101 and THP-00103 telmisartan 40 mg combination therapy group among subjects with type 2 diabetes mellitus accompanied by essential hypertension
Detailed Description:
None
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