Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202107579572114 Date of Approval: 20/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title deliVERy of Optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria
Official scientific title Evaluation of a triple single-pill combination (triple pill)-based treatment protocol compared to the Nigeria hypertension treatment protocol for improving BP control in Nigeria.
Brief summary describing the background and objectives of the trial High blood pressure (BP) is the leading cause of preventable morbidity and mortality globally. The benefits of BP lowering in reducing cardiovascular (CV) events are well established and there is clear evidence that greater BP lowering confers a greater reduction in CV events. However, control of high BP is poor globally. It is estimated that in SSA on average only 7% achieved BP control. This study is undertaken to investigate, among Black African adults with high BP, who are untreated or receiving monotherapy, if a triple single pill combination-based treatment protocol compared to the Nigeria hypertension treatment protocol is efficacious, safe, and feasible to implement for improving BP control in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VERONICA Nigeria
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2021
Actual trial start date 01/07/2022
Anticipated date of last follow up 31/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
TGI HTN NIG 2021 01 The George Institute for Global health
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Triple pill based treatment protocol Dose will be based on the Blood pressure of the participants and the treating physician's discretion 6 months from randomization Participants in this group will be treated following te triple pill (Combination of Telmisartan+ Amlodipine+ Indapamide)based treatent protocol. Additional add on therapy will be as per the discretion of the investigator based on the individual participant BP control 150
Control Group Nigeria hypertension treatment protocol Dose will be based on the Blood pressure of the participants and the treating physician's discretion 6 months from randomization Participants in this group will be treated following the Nigerian hypertension protocol & all participants will be given life style advice. Additional add on therapy will be as per the discretion of the investigator based on the individual participant BP control 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
At screening visit 1. Black African 2. Adult (age ≥18 years) 3. Provided signed consent to participate in the study 4. Untreated or on one BP-lowering medication for ≥2 weeks 5. Needs initiation or intensification of BP-lowering medication(s) therapy as per the investigator’s judgement based on BP at this and/or previous visits 6. Willingness to use home BP measurement device and measure BP at home for 6 months At randomisation visit 1. Untreated or on one BP-lowering medication for ≥2 weeks 2. Clinic attended automated seated mean SBP (average of last 2 measurements): 140-179 mmHg and/or DBP 90- 109 mmHg 3. Willingness to use home BP measurement device and measure BP at home for 6 months 4. Needs initiation or intensification of BP-lowering medication(s) therapy as per the investigator’s judgement based on BP at this and/or previous visits At Screening and randomisation visit 1. Receiving 2 or more BP-lowering medications. (a single pill combination containing two different BP-lowering medications should be considered as 2 BP-lowering medications) 2. Receiving any BP lowering medications for indications other than hypertension (e.g., heart failure) 3. Current/history of congestive heart failure 4. Current/history of coronary heart disease including angina, myocardial infarction, or acute coronary syndrome 5. Current/history of atrial fibrillation 6. Current/history of a stroke or transient ischemic attack 7. Known or suspected secondary hypertension 8. Hyper-/hypothyroidism, pheochromocytoma, or arteriovenous fistula 9. Current/history of Raynaud’s disease 10. Uncontrolled diabetes mellitus (glycosylated haemoglobin >11% [> 97 mmol/mol]) within last three months 11. Current/history of end-stage renal disease or anuria or current estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2) 12. Pregnancy, or had a positive pregnancy test, or unwilling to undertake a pregnancy test before randomisation, and/or during the study, and up to 14 days after the discontinuation of the study medication, or breastfeeding, or of childbearing age and not using highly effective method of contraception 13. Not suitable for participation in a clinical study according to local ethical or regulatory requirements related to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) 14. Contraindication, including hypersensitivity (e.g., anaphylaxis or angioedema) to any of the study medications or procedures 15. Participation in any investigational medication and/or device study within the 30 days prior to randomisation 16. Current concomitant illness or physical impairment or mental condition or abnormal laboratory value, which in the judgment of the investigator could interfere with the effective conduct of the study or constitutes a significant risk to the participants’ safety or well-being 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 29/06/2021 University of Abuja Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Abuja Teachning Hospital Gwagwalada P.M.B 228 FCT Abuja 902101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difference in change in home seated mean SBP from randomisation to month 6 After 6 Months after randomization
Secondary Outcome Percentage of participants with clinic seated mean SBP <140 mmHg and DBP <90 mmHg at month 6 6 Months after randomization
Secondary Outcome Difference in change in home seated mean SBP from randomisation to month 1, 2, and 3 Randomization to 3 month visit
Secondary Outcome Mean time to first week of home seated mean SBP <130 and DBP <80 mmHg 1 week after randomization
Secondary Outcome Mean time at home seated mean SBP <130 and DBP <80 mmHg from randomisation to month 6 6 Months after randomization
Secondary Outcome Difference in change in home seated mean DBP from randomisation to month 1, 2, 3, and 6 At month 1, 2, 3, and 6 after randomization
Secondary Outcome Percentage of participants with clinic seated mean SBP <140 mmHg and DBP <90 mmHg at month 1, 2 and 3 At month 1, 2 and 3 after randomisation
Secondary Outcome Percentage of participants with home seated mean SBP <130 mmHg and DBP <80 mmHg at month 1, 2, 3, and 6 At month 1, 2 and 3 after randomisation
Secondary Outcome Difference in change in clinic seated mean SBP and DBP from randomisation to month 1, 2, 3, and 6 At month 1, 2, 3, and 6 after randomization
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiovascular Research Unit First floor NHIS Family Medicine Complex University of Abuja Teaching Hospital Gwagwalada, Abuja, Nigeria Abuja 902101 Nigeria
Aminu Kano Teaching Hospital Cardiology Unit, Department of Medicine, P.M.B 3452, No. 1 Zaria Road Kano State Nigeria Kano 700233 Nigeria
University College Hospital Ibadan Cardiology Division, Department of Medicine, PMB5116 Ibadan, Oyo State, Nigeria Ibadan 200005 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
National Health and Medical Research Council NHMRC 16 Marcus Clarke St, Canberra ACT 2601 Canberra 2601 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The George Institute for Global Health Level 5, 1 King Street Newtown, Sydney, NSW 2042, Australia Sydney 2042 Nigeria Medical research institute
COLLABORATORS
Name Street address City Postal code Country
George Institute Services India Private Limited Level 2, Elegance Tower Plot No. 8, Jasola District Centre New Delhi New Delhi 110025 India
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dike Ojji dike.ojji@uniabuja.edu.ng 0023408060094456 Cardiovascular Research Unit, First floor, NHIS/Family Medicine Complex University of Abuja Teaching Hospital Gwagwalada, Abuja
City Postal code Country Position/Affiliation
Anuja 902101 Nigeria Consultant Caridiologist University of Abuja Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Dike Ojji dike.ojji@uniabuja.edu.ng 0023408060094456 Cardiovascular Research Unit, First floor, NHIS/Family Medicine Complex University of Abuja Teaching Hospital Gwagwalada, Abuja
City Postal code Country Position/Affiliation
Abuja 902101 Nigeria Consultant Caridiologist University of Abuja Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Anthony Rodgers arodgers@georgeinstitute.org 0061280524375 Level 5, 1 King Street, Newtown, Sydney Sydney 2042 Australia
City Postal code Country Position/Affiliation
Sydney 2042 Australia Head Cardiovascular Program The George Institute for Global Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will not be shared. The intention is to publish the results in aggregate in a peer reviewed journal within 12 months of completion of the trial, and not to share IPD. We will also provide link to summary results on the PACTR within 12 months of completion of the trial. Clinical Study Report Not Applicable-IPD will not be shared. Not Applicable- IPD will not be shared.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information