Comparative Effects of Perindopril and Zofenopril on Blood Pressure Control and Oxidative Status Blacks Hypertensive Patients. (PEZO-HP)

Rationale and Design of a Simple Randomized Trial Evaluating Comparative Effects of Perindopril and Zofenopril in Blacks Hypertensive Patients: Short Term Effects on Cardiac and Oxidative Status With Perindopril or Zofenopril (PEZO-HP) Trial

The aim of the study is to compare the short term effect of perindopril and zofenopril in the management of hypertension and the oxydative stress in blacks hypertensive patients.

PEZO-HP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Perindopril Arginine; Drug: Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer

Detailed Description

Aim: to determine and compare the short term effect of angiotensin converting in the management of hypertension as well as the oxidative effect of Zofenopril and perindopril in blacks hypertensive patients in the Yaoundé Central Hospital.

Method: A double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital. Hypertensive patients who are not taking angiotensin-converting enzyme inhibitor or angiotensin receptors blockers, are randomize into 2 groups. Depending on the group, the intervention consisted of the administration of Perindopril 10 mg daily or Zofenopril 30 mg daily for 08 weeks. The endpoints were the nycthemeral blood pressure profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (Ferric reducing antioxidant).

Progress: Recruitment for PEZO-HP was completed in May 2019 with 24 patients.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Cameroon
  • Yaounde, Cameroon
    • Yaounde Central Hospital, Cardiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hypertensive patients
• On a stable atihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. The pharmacological treatment should not include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker
• Subject must not present any contraindication to exercise
• Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

• Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
• Withdrawal of consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Perindopril Arm; 10 mg Perindopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.	Drug: Perindopril Arginine; 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.; Other Names: Perindopril
Active Comparator: Zofenopril Arm; 30 mg Zofenopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.	Drug: Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer; 30 mg Zofenopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.; Other Names: Zofenopril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nycthemeral blood pressure profile (mmHg)	Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)	Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer	8 weeks
Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol)	Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer	8 weeks

Collaborators and Investigators

• Sponsor: Yaounde Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Blood pressure; Angiotensin II Receptor Blockers; Angiotensin Converting Enzymes Inhibitor; Oxidative status
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Calcium-Regulating Hormones and Agents; Angiotensin-Converting Enzyme Inhibitors; Calcium; Perindopril; Captopril; Zofenopril
• Other Study ID Numbers: PEZO-HP study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No