Canrenone as Add-on in Patients With Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

Efficacy and Safety of Canrenone as Add-on in Patients With Essential Hypertension-Italy (ESCAPE-IT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687178
• Other study ID #: 2010-023606-13
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2016
• Last updated: March 30, 2016
• Start date: October 2010
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage.

Exclusion Criteria:

• diabetes mellitus

• secondary hypertension

• pregnancy

Study Design

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Canrenone 50 vs canrenone 100 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic (SBP) and Diastolic blood pressure reduction		3 months	Yes