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

Sponsor

Yaounde Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04254042

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Perindopril Arginine Drug: Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

PEZO-HP trial is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, CameroonPEZO-HP trial is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon

Masking:

Double (Participant, Investigator)

Masking Description:

The double-blind model is applied to the study. Only the adjudicator, responsible for the distribution of medication knew the different regimes. Perindopril and Zofenopril were packaged in boxes of identical appearance and labeled for each participant by name and number of the randomization program. The randomization and packaging of the drugs was done by an investigator who had no clinical involvement.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.