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: 2015-10-21
Trial Status: Completed
TRIAL DESCRIPTION
Public title COmparative Study of CArdiovascular risk Reduction of Different Statins in Nigerian Hypertensives.
Official scientific title COmparative Study of CArdiovascular risk Reduction of Different Statins in Nigerian Hypertensives.
Brief summary describing the background
and objectives of the trial
Hypertension is a major risk factor for cardiovascular disease (CVD). It is also a major cause of mortality globally. Dyslipidaemia acts synergistically with hypertension in increasing CVD. There is therefore an ever-growing need for the judicious use of statins in patients at risk of CVD. This drugs have varying lipid lowering and pleiotropic properties. To this end we hope to compare lipid lowering and pleiotropic effects of Rosuvastatin,Simvastatin and Artovastatin in our patients.
Type of trial Treatment
Acronym (If the trial has an acronym then please provide) COmparative Study of CArdiovascular risk Reduction of Different Statins in Nigerian Hypertensives.
Disease(s) or condition(s) being studied Hypertensive patients with dyslipidemia.
Purpose of the trial
Anticipated trial start date 2015-12-01
Actual trial start date 2015-12-01
Anticipated date of last follow up 2017-06-10
Actual date of last follow up 2017-06-10
Anticipated target sample size (number of participants) 400   
Actual target sample size (number of participants) 400   
Recruitment status Not yet recruiting
No Secondary ID Issuing authority/Trial register

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 Randomised Permuted block randomisation, blocks of 6 sealed opaque envelopes. Masking/blinding used Participants,Outcome Assessors,

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control

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

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

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

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country

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
Dr Bertha Ekeh UUTH, Uyo.Nigeria uyo 530001 Nigeria
Dr Udeme Ekrikpo UUTH, Uyo.Nigeria uyo 530001 Nigeria
Prof A. Ogunniyi UCH Ibadan 200284 Nigeria

CONTACT PEOPLE
Role Name Email Phone Fax