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.: PACTR202407549032623 Date of Approval: 23/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of amlodipine on oxidative stress among adult Nigerian hypertensives: an exploratory randomised control trial (AMLOX-NH)
Official scientific title Effect of amlodipine on oxidative stress among adult Nigerian hypertensives: an exploratory randomised control trial (AMLOX-NH)
Brief summary describing the background and objectives of the trial Hypertension is a significant global health challenge. Its pathogenesis involves a complex interplay of factors, including oxidative stress, which contributes to endothelial dysfunction and adverse cardiovascular outcomes. Thus, antihypertensive drugs that reduce oxidative stress could offer significant benefits. This study hypothesizes that amlodipine has antioxidant effects and aims to determine its effect as a vascular modulator of oxidative stress among Nigerian hypertensives.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AMLOXNH
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 12/08/2024
Actual trial start date
Anticipated date of last follow up 28/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
HRECPAN20240250637 DELSUTH HREC
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Amlodipine 5mg - 10mg once daily Eight weeks The test group will be given 5mg of amlodipine once daily as an intervention. Participants who do not achieve target BP control (i.e., BP <140/90mmHg) four weeks after baseline will have the daily dose of their study drug doubled (i.e., tab amlodipine increased from 5mg to 10mg) 22
Control Group Hydrochlorothiazide 12.5mg - 25mg once daily Eight weeks The control group will receive hydrochlorothiazide 12.5mg once daily as an intervention. Participants who do not achieve target BP control (i.e., BP <140/90mmHg) four weeks after baseline will have the daily dose of their study drug doubled (i.e., tab hydrochlorothiazide increased from 12.5mg to 25mg). 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 35 - 65 years Systolic blood pressure of 140mmHg and above and less than 180mmHg Participants with severe hypertension (BP ≥180/110mmHg) Patients with suspected secondary hypertension Participants with a history of use of antihypertensive medications, statins, anti-platelets, and vitamin C supplements in the past three months before the screening date. Participants with eGFR<35ml/min/1.73m2, congestive cardiac failure, transient ischaemic attack or stroke, acute or chronic coronary syndrome, and hepatic failure. Participants with mental impairment capable of interfering with the conduct of the study. Pregnant women and women of childbearing age who are not on effective contraception. Unwillingness to provide written informed consent. Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 65 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
Yes 24/05/2024 DELSUTH Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
c/o Department of Surgery, Delta State University Teaching Hospital, Oghara, Delta State Oghara 331101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean change in levels of oxidative stress biomarkers, malondialdehyde (MDA) and superoxide dismutase (SOD) from baseline to 8 weeks of study drug use. Baseline and 8-weeks
Secondary Outcome Reduction in systolic and diastolic BP after use of amlodipine for eight weeks. Baseline, 2-weeks, 4-weeks, and 8-weeks
Secondary Outcome Differences in blood pressure (SBP and DBP), estimated glomerular filtration rate (eGFR), fasting blood glucose (FBS) and fasting serum lipid profile (FSLP) between the study group and control Baseline and 8-weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital Oghara Ibori road, Ogharefe 2 Oghara Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ejiroghene Martha Umuerri 107b Oghene road Sapele Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ejiroghene Umuerri 107b Oghene road Sapele Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ejiroghene Umuerri umuerriejiro@gmail.com +2348033487741 Department of Medicine, Delta State Univeristy
City Postal code Country Position/Affiliation
Abraka Nigeria Professor Delta State University
Role Name Email Phone Street address
Public Enquiries Afeyodion Akhator hrecdelsuth@gmail.com +2348067636273 c/o Department of Surgery, Delta State University Teaching Hospital
City Postal code Country Position/Affiliation
Oghara Nigeria Chairman DELSUTH HREC
Role Name Email Phone Street address
Scientific Enquiries Dike Ojji dike.ojji@uniabuja.edu.ng +2348060094456 Department of Medicine, University of Calabar
City Postal code Country Position/Affiliation
Calabar Nigeria Adjunct Professor University of Calabar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data to be shared will include de-identified individual participant data that underlie the results reported in published articles. The data will consist of baseline demographics, clinical characteristics, oxidative stress biomarkers, blood pressure measurements, and any other variables collected in the study. Informed Consent Form,Study Protocol Data will be available for sharing beginning six months after the publication of the primary results. Data will be available for five years after initial data sharing. Qualified researchers affiliated with academic institutions, research organizations, or healthcare entities can request access to the data. Researchers must submit a formal request to the Principal Investigator, including a summary of the research proposal and objectives, a description of the data requested and the analysis plan, and information about the research team and their qualifications. Researchers who are granted access to the data must sign a Data Use Agreement (DUA) that includes the following conditions: 1. Data will be used solely for the purpose outlined in the approved research proposal. 2. Data will be kept secure and confidential and not shared with third parties without prior approval. 3. Results of the secondary analysis will be shared with the original investigators before publication. 4. Any publications resulting from the use of the shared data must acknowledge the original study and its investigators.
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