Clinical trial protocol
Clinical Trial Protocol
Post-Marketing Surveillance (PMS) Study
An Observational Study on the Efficacy, Safety and Tolerability of Revosyl® in Managing
Patients with Essential Hypertension in Actual Medical Practice in Syria
Clinical trials of different types have shown clearly that high blood pressure
is associated with increased cardiovascular morbidity and mortality, and lowering
of high blood pressure reduces these events, (heart failure, myocardial infarction ,
Suppression of the Renin-Angiotensin Aldoestrone System (RAAS) by means of
Angiotensin Converting Enzyme (ACE) inhibitors has been employed
successfully for long time in the management of essential hypertension. However,
we don’t have a study about efficacy, safety and tolerability of ACEIs in actual
Prior to participation in this study, Ibn-Alhaytham Pharmaceutical Industry
cardiovascular line -medical representatives will visit the selected participating
physicians for signing up an agreement from indicating physician's acceptance to
conduct the study according to the provided protocol and to hand over to the
company the Completed Case Report Form for each patient after study
Each participating physician will receive a copy of the study drug product leaflet
with details of indications, contraindications and dosage etc…
A meeting will be conducted with participating physicians for introducing the
study and having the agreement form signed. Another meeting will be organized
of the study completion and data analysis to introduce the results.
Ibn-Alhaytham Pharma will assign medical representatives to conduct regular
follow up visits to all participating physicians in Syria.
Methods and Objectives:
Previous studies with Perindopril / Coversyl™ have been conducted on
patients with hypertension but no large scale study has been conducted on
Perindopril produced by National Pharmaceutical Company in Syria. Controlled
clinical trials cannot provide data which reflect actual real life usage of the drug.
This is an observational, prospective, open label, post marketing, non
interventional drug monitoring program to collect data on the usage of Revosyl™
in daily medical practice conditions in Syria and in line with the current applicable
This Study aims at evaluating efficacy, safety and tolerability of Revosyl™
(Ibn-Alhaytham) given as monotherapy or as a part of a combination
regimen with other antihypertensive agents in management of patients with
essential hypertension as per actual medical practice in Syria.
This study involves follow up of large numbers of patients' sample (2250
patients) over 12 weeks follow up period.
From previous data the maximum reduction of blood pressure is achieved
within 1-2 weeks from starting medication.
Trial Patients & Physicians:
Patients should meet certain criteria in order to be included in the study.
This study will be conducted out on 2250 Stage I & Stage II hypertensive
patients either newly diagnosed (preferable) or uncontrolled on their current
1) Essential hypertension with stage I, II or ISH (preferably newly
1) Patients already on ACEI (unless discontinued > 2 weeks).
2) Significant Renal Failure (Creatinine > 3 , K > 5.5).
One hundred and fifty physicians (Internists, Cardiologists, Nephrologists
and Neurologists) from all major provinces in Syria will be selected. Each
participating physician will be asked to provide complete data on 15 patients
he/she has decided to treat with Revosyl™ (Ibn-Alhaytham)
The name of the participating physician will not be disclosed. The Data from any
studied patient will not be disclosed and will be used only for the sake and the
This study does not require approval of an independent ethical committee as the
protocol requires only observation and data reporting and describes no
intervention in the management and/or behavior of the patient and doesn’t have
deviation from usual medical practice.
Patient's informed consent will not be needed as this is an observational PMS
A Case Report Form will be provided for data collection.
Medication and Dosage
Revosyl™ 4 mg or Revosyl™ 8 mg given once daily according to physician
decision and as per the basic prescribing information of the product.
This is will be done on the safety , efficacy and tolerability of Revosyl by Dr.
1. Reporting any adverse drug reaction with clear data about its type,
date & time of onset resolution and global relationship to trial treatment.
2. Overall assessment of tolerability will be evaluated at last visit.
Blood pressure change from baseline (systolic and diastolic).
Overall assessment will be stated by the investigator at last visit.
This will document if blood pressure is controlled or not (SBP below 140
mmHg & DBP below 90 mmHg) in essential non complicated hypertension
Questions & Contacts:
Walid Bsata, MD, FRCPI , FACP
General Director, Aleppo University Heart Hospital.
Executive Board Member, Syrian Cardiovascular Association
Mohammed Asmi, MD, DCC, FESC
Consultant Cardiologist , Cardiac Department Assad University Hospital,Damascus, Syria
Member of the Syrian Cardiovascular Association
Health Research Consultant
Samer Rastam, MD, PhD
Aleppo University, Faculty of Medicine, Aleppo, Syria
Dr. Noman Dormosh
Special Article Accepted: April 30, 2009 Published online: August 27, 2009 Psychosomatic Assessment Giovanni A. Fava a, d Nicoletta Sonino b–d a Department of Psychology, University of Bologna, Bologna , and Departments of b Statistical Sciences and c Mental Health, University of Padova, Padova , Italy; d Department of Psychiatry, State University of New York Key Words the
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