NCT02687178

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

5 years

First QC Date

February 17, 2016

Last Update Submit

March 30, 2016

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic (SBP) and Diastolic blood pressure reduction

    3 months

Study Arms (2)

Canrenone 50 mg

ACTIVE COMPARATOR

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

Drug: Canrenone 50 vs canrenone 100 mg

Canrenone 100 mg

ACTIVE COMPARATOR

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

Drug: Canrenone 50 vs canrenone 100 mg

Interventions

Canrenone 50 vs canrenone 100 mgDRUG
Canrenone 100 mgCanrenone 50 mg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • diabetes mellitus
  • secondary hypertension
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Derosa G, Maffioli P, D'Avino M, Sala C, Mugellini A, Vulpis V, Felis S, Guasti L, Sarzani R, Bestetti A, Vanasia M, Gaudio G; ESCAPE-IT Trial Investigators group. Efficacy and safety of two dosages of canrenone as add-on therapy in hypertensive patients taking ace-inhibitors or angiotensin II receptor blockers and hydrochlorothiazide at maximum dosage in a randomized clinical trial: The ESCAPE-IT trial. Cardiovasc Ther. 2017 Feb;35(1):47-54. doi: 10.1111/1755-5922.12235.

    PMID: 27860389DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FESC

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 22, 2016

Study Start

October 1, 2010

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

April 1, 2016

Record last verified: 2016-03