Nigeria Clinical Trial Registry
Federal Ministry of Health
Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: info@nhrec.ne

Trial No: 0
Date registered: 2021-07-07
Trial Status: Pending
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 is the leading cause of preventable morbidity & mortality 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, &feasible to implement for improving BP control in Nigeria.
Type of trial Treatment
Acronym (If the trial has an acronym then please provide) VERONICA-Nigeria
Disease(s) or condition(s) being studied Hypertension
Purpose of the trial
Anticipated trial start date 2021-09-01
Actual trial start date 2021-09-01
Anticipated date of last follow up 2022-04-30
Actual date of last follow up 2022-04-30
Anticipated target sample size (number of participants) 108   
Actual target sample size (number of participants) 108   
Recruitment status Not yet recruiting
No Secondary ID Issuing authority/Trial register
11 1

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
Single group Non-randomised 1 sealed opaque envelopes. 1 Participants,Outcome Assessors,1

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group dgrviwoa 1 1 1 Active
Control group nbmxyaxi 1 1 1 Active
Experimental group opicgrhh 1 1 1 Placebo
Control group oeqonksh 1 1 1 Placebo
Experimental group bkvtlsmy 1 1 1 Historical
Control group lrjwbdsa 1 1 1 Uncontrolled
Experimental group djkfgswy 1 1 1 Uncontrolled
Control group fwedfgae 1 1 1 Historical
Experimental group ncbfnmyn 1 1 1 Dose comparison
Control group uoqkquom 1 1 1 Dose comparison

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1 1 1 1 1

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
0000-00-00 0000-00-00 mciacekw
Ethics Committee Address
Street address City Postal code Country
3137 Laguna Street San Francisco 94102 Afghanistan
0000-00-00 0000-00-00 oohbxeng
Ethics Committee Address
Street address City Postal code Country
3137 Laguna Street San Francisco 94102 Afghanistan

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 1 1

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
1 3137 Laguna Street San Francisco 94102 Afghanistan
1 3137 Laguna Street San Francisco 94102 Albania
1 3137 Laguna Street San Francisco 94102 Algeria

FUNDING SOURCES
Name of source Street address City Postal code Country

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor

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 110025 India

CONTACT PEOPLE
Role Name Email Phone Fax