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
REST Trial
Introduction:
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 Organization:
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.
Follow up:
Ibn-Alhaytham Pharma will assign medical representatives to conduct regular follow up visits to all participating physicians in Syria.
Trial Period:
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 Systolic
BP Category
Diastolic (mmHg)
Inclusion Criteria:
1) Essential hypertension with stage I, II or ISH (preferably newly Exclusion criteria:
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 Documentation:
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.
Statistical Analysis
This is will be done on the safety , efficacy and tolerability of Revosyl by Dr.
Overall Assessments:
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:
Primary Investigator
Walid Bsata, MD, FRCPI , FACP
General Director, Aleppo University Heart Hospital.
Executive Board Member, Syrian Cardiovascular Association Co-Primary Investigator
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 Company Representatives:
Dr. Noman Dormosh
Dr.Yamen Shehadeh

Source: http://www.resttrial.com/REST-Protocol.pdf