Comparative Effects of Perindopril and Zofenopril on Blood Pressure Control and Oxidative Status Blacks Hypertensive Patients.

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer; Drug: Perindopril Arginine

• Registration Number: NCT04254042
• Lead Sponsor: Yaounde Central Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Last Update Submitted: 2020-01-31
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zofenopril Arm	Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer	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.
Perindopril Arm	Perindopril Arginine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yaounde Central Hospital, Cardiology department; 🇨🇲 Yaounde, Cameroon