Canrenone as Add-on in Patients With Essential Hypertension

U

University of Pavia

Status and phase

Completed
Phase 4

Conditions

Essential Hypertension

Treatments

Drug: Canrenone 50 vs canrenone 100 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02687178
2010-023606-13

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

Canrenone 50 mg
Active Comparator group
Description:
Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage.
Treatment:
Drug: Canrenone 50 vs canrenone 100 mg
Canrenone 100 mg
Active Comparator group
Description:
Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage.
Treatment:
Drug: Canrenone 50 vs canrenone 100 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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