ISRCTN - ISRCTN69089076: Observational study on the hypertensive patients treated with Perindopril-Amlodipine

Plain English Summary

Background and study aims
Cardiovascular diseases are a leading cause of death worldwide and high blood pressure
remains the leading risk factor for early death and is responsible for 7.5 million deaths worldwide, according to a report from the World Health Organization. Recent reports suggest that nearly one billion people had high blood pressure in 2000 and this will increase to around 1.56 billion by 2025. Treating high blood pressure reduces the risk of heart disease by 16% and stroke by 36%. Although lifestyle modifications, such as quitting smoking, losing weight and changes in diet can help reduce blood pressure (BP), many patients also need drug therapy. This study aims to find out the effectiveness and safety of different recommended doses of a Perindopril/Amlodipine fixed dose combination treatment (COVERAM).

Who can participate?
Patients already treated for moderate to severe high blood pressure who have not developed any heart disease can participate in this study.

What does the study involve?
There are no medical procedures involved in this study. Patients must be already on COVERAM prior to the study enrollment and the treatment of patients should be done according to the normal clinical practices. Patients who are not on COVERAM will receive a diuretic drug (increases production of urine) as an add on.

What are the possible benefits and risks of participating?
Participants will have the chance of achieving blood pressure control according to their background therapy, further diseases and number of risk factors for heart disease. Common side effects (occur in less than one in ten users) include headache, dizziness, pins and needles, sleepiness, vision disturbances, sensation of noise in the ears, very fast heartbeat, flushing (hot or warm feeling in your face), light-headedness due to low blood pressure, cough, shortness of breath, nausea (feeling sick), vomiting (being sick), abdominal pain, taste disturbances, difficulty in digesting food, watery stool, constipation, allergic reactions (such as skin rashes, itching), muscle cramps, feeling of tiredness, swelling of legs or ankles.

Where is the study run from?
The study will be running in 70 sites (private clinics) across Egypt.

When is the study starting and how long is it expected to run for?
The study starts in August 2013. Patients will be recruited for 3 months. The duration of the treatment is 3 months.

Who is funding the study?
The study is sponsored by Servier Egypt Scientific Office, Egypt.

Who is the main contact?
Dr Ahmed Bedair
Tel: +201272003088
ahmed.bedair@eg.netgrs.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mohamed Sobhy

ORCID ID

Contact details

Director of cardiac cath. Lab
Alexandria University
Cardiac Center hospital
Alexandria
21599
Egypt
+201222150381
sobhy53@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-05985-001-EGY

Study information

Scientific title

Open labeled Non-Interventional Study to assess EffiCacy & tolerability evaluation of PerindOpril-AmlodipiNe fixed dose combinaTion with oR without addition of Diuretics for uncOntrolled hypertensive patients in the cLinical setting, CONTROL Study

Acronym

CONTROL

Study hypothesis

"CONTROL study" is an observational study to assess efficacy & Safety evaluation of Perindopril-Amlodipine
fixed dose combination with or without addition of Diuretics for uncontrolled hypertensive patients in the clinical setting.

Coveram - summary of product characteristics
http://www.servier.com/sites/default/files/FR-H-325-01-04-Compiled%20PI-EU-20100429.pdf

Ethics approval

The study was approved on 04/06/2013 from the Ethics committee of the Egyptian Ministry of Health and Population-Central Directorate for Research and Health Development. Approval number: 18-2013/4

Study design

Multicenter prospective non-interventional study with 3 months follow up

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular area-Hypertension

Intervention

CONTROL study is a multicenter, prospective, Non-Interventional, study among hypertensive patients with
3 months follow up. The study will be approved by local institutional review boards and all patients will give
informed consent in accordance with national and local guidelines.

Duration of study participation:
Study enrollment period is expected to be Three months starting from 1/7/2013.
Each subject should receive at least one dose of COVERAM prior to the study enrollment period.
Screening period should be after first dose of COVERAM and prior to follow-up period.
The study will be considered completed for a patient at the time he/she completes three months of the study duration.

Intervention type

Drug

Phase

Not Applicable

Drug names

COVERAM (Perindopril-Amlodipine)

Primary outcome measure

According to the guidelines and the normal clinical practice: at the doctors office after 5 min of rest, sitting position. Three BP measurements have to be taken and the mean of the last two will be used for the calculation of mean.
Assessment of Study Medicines:
Efficacy: Reduction in blood pressure to target values (140/90 mmHg or 130/80 mmHg, in patients with
diabetes mellitus).
Safety: Occurrence of any side effect leading to treatment discontinuation.
All side effects will be monitored at each visit following the baseline visit during the study period.

Secondary outcome measures

1. Percentage of patients achieving blood pressure control according to their background therapy, co-morbidity & number of cardiovascular risk factors.
2. Percentage of patients achieving blood pressure control with the different doses of Perindopril/Amlodipine combination or after adding Indapamide 1.5 mg SR or other treatment modification.
3. Effect of perindopril/Amlodipine combination with or without Indapamide SR or other treatment
modification on short-term intravisit BPV and long-term visit-to-visit variability in SBP & DBP, its relationship
with patient risk factors & comorbidities
4. Occurrence of any side effects leading to treatment discontinuation.

Overall trial start date

01/08/2013

Overall trial end date

15/01/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Subjects meeting all of the following criteria will be considered for enrollment into the study:
1. Men or women with age between 30 and 75.
2. Patients with proved hypertension, a baseline mean BP > 140/90 mm Hg with or without Diabetes Mellitus type II.
3. Patients should be taking Coveram prior to enrollment in the study.
4. All patients will be treated for their hypertension with COVERAM as per the decision of the treating physician and according to the Product information leaflet PIL. The decision for treatment with COVERAM will be made by the treating physician, based on medical judgment, prior to assessment of eligibility for the study. The management of the patient by the treating physician including the initiation of treatment with COVERAM will be independent and not affected by participation in the study.
5. Medical history of the patients should include switching of uncontrolled hypertensive patients on at least two medications to Coveram prior to the enrollment of the patients in the study.
6. Medical history of the patients should include switching to COVERAM from previous antihypertensive medication including at least 2 medications amongst ACEIs, ARBs, Diuretics & CCBs.
7. The patient must read, sign and receive a copy of the informed consent prior to study enrollment.
8. Patients registered to this study must be treated and followed up at the participating center according to the normal clinical practice.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant exclusion criteria

Subjects presenting with any of the following criteria will not be included in the study:
1. Newly diagnosed hypertensive patients not receiving any treatment at baseline or uncontrolled hypertensive patients receiving only one medication.
2. Hypertensive patients already treated with beta blockers at baseline or those with medical conditions that require to be treated with BB according to guidelines.
3. Patients with secondary hypertension.
4. Patients with stable coronary artery disease including those with MI history or stable angina pectoris.
5. Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina pectoris within the past 6 months.
6. Hypertensive encephalopathy, stroke, or transient ischemic attack within the past 12 months.
7. New York Heart Association functional class I-IV congestive heart failure.
8. Hemodynamically significant cardiac valvular disease, Cardiac arrhythmias, sinus tachycardia.
9. Significant chronic renal impairment defined by estimated Glomerular Filtration Rate as those having eGFR ≤ 60 ml/min/1.73 m2.
10. Significant liver disease as shown by SGPT/SGOT 2.5 times the upper limit of the normal range.
11. Gastrointestinal disease or surgery that might interfere with drug absorption.
12. Malignancy during the past 5 years.
13. Currently pregnant or lactating females.
14. Women of childbearing potential not protected by effective contraceptive method of birth control and/or
who are unwilling or unable to be tested for pregnancy.
15. Known hypersensitivity to Perindopril, other ACEIs, Amlodipine, other CCB, Indapamide, other thiazide diuretic or other antihypertensive treatment use during the follow-up.
16. Simultaneous or previous participation in the 90 days prior to study entry in a clinical trial using an
experimental drug or device.
17. Medical, psychiatric, or neurologic condition that renders the patient unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent.
18. Any medical condition that in judgment of the investigator would jeopardize the patients safety or the study drugs evaluation for efficacy and safety.
19. Any of the contraindications linked to Perindopril, Amlodipine or COVERAM

Recruitment start date

01/08/2013

Recruitment end date

15/01/2014

Locations

Countries of recruitment

Egypt

Trial participating centre

Director of cardiac cath. Lab
Alexandria
21599
Egypt

Sponsor information

Organisation

Servier Egypt Scientific Office (Egypt)

Sponsor details

67 El Horreya St. - Off EL Nozha
Heliopolis
Cairo
11351
Egypt
+202 22906077
ahmed.bedair@eg.netgrs.com