Hypertension thErapy with irBesartan Versus epleRenone for Obese hypertensive patients: A Randomized Clinical Trial

Phase 1

• Conditions: Primary Hypertension and Obesity; MedDRA version: 21.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004809-58-GR
• Lead Sponsor: Institute for study, research, education and therapy of vascular, heart, brain and kidney nosologies (I.N.A.K.E.N)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 340

Inclusion Criteria

1. 30-75 years of age
2. Untreated or never-treated arterial hypertension with office systolic blood pressure of 140-180 mmHg and/or diastolic blood pressure of 90-120 mmHg
3. Confirmation of arterial hypertension by 24-hour ambulatory blood pressure measurements of mean ambulatory systolic blood pressure over 130 mmHg and/or mean ambulatory diastolic blood pressure over 80 mmHg
4. Obesity, confirmed estimated by Body Mass Index (BMI) of 30-39.99 kg/m2
5. ?nformed written consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participation in a clinical trial with an Investigational Product or an invasive device during the study or the last 6 months
2. Secondary arterial hypertension
3. Recent (<6 months) cardiovascular event :
- myocardial infarction,
- unstable angina
- stroke)
4. Type 1 diabetes mellitus
5. Heart failure with reduced ejection fraction (EF<40%)
6. Chronic kidney disease assessed by eGFR<45mL/min/1,73m2
7. Bilateral renal arteries stenosis
8. Patient with hyperkalaemia (> 5.5)
9. Hemodynamically significant valvular heart diseas
10. Addison’s disease
11. Pregnancy, planning to conceive or women of childbearing potential, not using effective contraception
12. Scheduled surgery or cardiovascular surgery over the next 6 months
13. Absolute contra-indication to any of the study drugs
14. Requirement for study drug for reason other than to treat hypertension, (eg, ß-blockers for angina or aldosterone antagonists for heart failure)
15. Neoplasm under treatment (radiotherapy / chemotherapy / immunotherapy)
16. Patient with a contemporary systemic disease with a life expectancy less than the end of the study
17. Any situation which, in the judgment of the investigator, may adversely affect the efficacy and / or safety of the Investigational Product (alcohol abuse, drug use, mental retardation)
18. Patient treated with systemic corticosteroids at least 3 months prior to the the study screening
19. Patient receiving a-inhibitors with the exception of aflucosin and tamsulosin for prostatic symptoms

Study & Design

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