The effect of spironolactone on kidney function in patients with high blood pressure

Phase 1

• Conditions: Physiological responses in patients with essential hypertension; MedDRA version: 20.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2019-001636-60-DK
• Lead Sponsor: niversity clinic of Nephrology and Hypertension, Regional Hospital Holstebro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-13
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

40-80 years, BMI 18,5-30,0 kg/m2, fertile women must use contraception, hypertension, signed consent form
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Alcohol abuse, substance abuse, tobacco smoking, cancer, pregnancy or nursing, diabetes mellitus, GFR < 60 ml/min, Albuminuria > 700 mg/l, clinically significant signs of lung-, liver-, metabolic or neurologic disorders, clinically significant abnormalities in screening blood tests, urine tests or ECG, clinical signs of secondary hypertension, treatment with more than 3 different types of antihypertensives, office blood pressure > 170/105 repeatedly despite regulaion og antihypertensive medicine, donation of blood within one month of the first examination day, uacceptable symptoms due to high blood pressure

Study & Design

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