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

NCT ID: NCT04254042

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-05-01

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Perindopril Arginine

Intervention Type DRUG

10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

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.

Group Type ACTIVE_COMPARATOR

Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer

Intervention Type DRUG

30 mg Zofenopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Interventions

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Perindopril Arginine

10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Perindopril Zofenopril

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yaounde Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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CN NGANOU-GNINDJIO, MD, MSc

Dr, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yaounde Central Hospital, Cardiology department

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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PEZO-HP study

Identifier Type: -

Identifier Source: org_study_id

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