Effect of the glucose-lowering drug dapagliflozin on vascular function and blood pressure

Phase 1

• Conditions: Arterial hypertension; MedDRA version: 20.0 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-004164-11-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

Inclusion criteria for the main study (short-term study):
1.Provision of informed consent prior to any study specific procedures
2.Men or post-menopausal women that express their willing to participate in the study by signing the informed consent
3.Subjects aged 30-69 years (inclusive)
4.T2DM patients with adequate glucose control (HbA1c<7.5%), achieved with any oral anti-hyperglycemic treatment, whose BP values are not at target (e.g. clinic BP >140/90 mmHg or home BP >135/85 mmHg despite a therapeutic dose of ACE-inhibitors
Inclusion criteria for the substudy (acute study):
1.Provision of informed consent prior to any study specific procedures
2.Men or post-menopausal women that express their willing to participate in the study by signing the informed consent
3.Subjects aged 30-69 years (inclusive)
4.T2DM patients with adequate glucose control (HbA1c<7.5%) achieved with any oral anti-hyperglycemic treatment, but treatment-naïve for hypertension whose blood pressure values are not controlled (e.g. clinic BP >140/90 mmHg or home BP >135/85 mmHg), in whose according to guidelines antihypertensive treatment is not yet compelling
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Clinic BP values > 160/100 mmHg
•eGFR<60ml/min/1.73 m2
•Patients with NYHA III/IV heart failure
•Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
•Total bilirubin >2.0 mg/dL (34.2 µmol/L)
•Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
•Volume depleted patients or those who, in the judgement of the investigator, may be at risk for dehydration (use of other diuretics, laxatives, chronic diarrhoea etc)
•History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin cancer
•Patients unable to give a valid informed consent;
•Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
•Patients who received any investigational new drug within the last 12 weeks;
•Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified