Canrenone as Add-on in Patients With Essential Hypertension

Status Completed

Clinical Trial Summary

Clinical Trial Description

To evaluate the efficacy on blood pressure reduction, safety and tolerability of two different dosages of canrenone as add-on therapy in patients already treated with Angiotensin Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics at the maximum dosage.

In this multi-centre, phase IV, randomized, controlled, open-label, parallel groups trial, 180 Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage will be enrolled.

At baseline patients will be randomized to canrenone, 50 mg, or canrenone 100 mg once a day, in addition to their current therapy, for three months.

At the baseline, and after 3 months will be evaluated: systolic (SBP) and diastolic blood pressure (DBP), pulse pressure (PP), heart rate, fasting plasma glucose (FPG), homeostasis model assessment insulin (HOMA-index), total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol, sodium, potassium, calcium, magnesium, uric acid, estimated glomerular filtration rate (eGFR), plasmatic urea, brain natriuretic peptide (BNP), aldosterone, and galectin-3. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02687178
Study type	Interventional
Source	University of Pavia
Contact
Status	Completed
Phase	Phase 4
Start date	October 2010
Completion date	January 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03708601` - Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)
Not yet recruiting	`NCT05503953` - Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS	Phase 3
Recruiting	`NCT05526703` - Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy	Phase 3
Completed	`NCT06395194` - Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension	Phase 3
Not yet recruiting	`NCT06418074` - Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity	N/A
Completed	`NCT02890173` - Study of CS-3150 in Patients With Essential Hypertension	Phase 3
Withdrawn	`NCT02096939` - Microvascular Function in Primary Aldosteronism	N/A
Completed	`NCT02944734` - Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension	Phase 2
Recruiting	`NCT01956786` - Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine	Phase 2/Phase 3
Completed	`NCT02553512` - Helius in Hypertension-I: The UK Hypertension Registry	N/A
Completed	`NCT01198249` - Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension	Phase 1
Completed	`NCT01001572` - Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension	Phase 3
Recruiting	`NCT00380289` - Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension	N/A
Completed	`NCT00139698` - Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension	Phase 3
Completed	`NCT00288184` - Uric Acid in Essential Hypertension in Children	Phase 2
Completed	`NCT01289886` - Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects	Phase 1
Not yet recruiting	`NCT06041529` - Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension	Phase 4
Completed	`NCT04470830` - A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
Completed	`NCT00758524` - A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension	Phase 2
Recruiting	`NCT05109013` - Juvenile Essential Arterial Hypertension and Vascular Function