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NCT05970237 Clinical Trial

A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

Hypertension Clinical Trial

Official title:
A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05970237
Other study ID # BR-DGF-OS-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 26, 2023
Est. completion date December 2024

Study information
Verified date August 2023
Source Boryung Pharmaceutical Co., Ltd
Contact Shinyoung Oh
Phone +82-2-708-8000
Email syoh@boryung.co.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension

Recruitment information / eligibility
Status Recruiting
Enrollment 9000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab. - Those who voluntarily signed a written personal information agreement to participate in this clinical study. - Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion. Exclusion Criteria: - Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.) - Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1) - Those who are expected to need insulin prescription during the study period - Pregnant women, breast-feeding women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Gachon University Gil Medical Center Incheon Namdong-gu

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Target blood pressure control rate 12weeks after administration
Primary Target blood glucose achievement rate 12weeks after administration
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