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Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans (Creole)

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 4

Locations

Nigeria

Study Type

Interventional

Intervention

Perindopril plus Amlodipine

Perindopril plus Hydrochlorothiazide

Amlodipine plus Hydrochlorothiazide

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with Sitting SBP ≥140 mm Hg and < 160 mmHg on one antihypertensive agen or
Sitting SBP ≥ 150 mm Hg and < 180 mm Hg on no antihypertensive treatment.

Exclusion Criteria:

Congestive heart failure (clinically defined).
Serum creatinine levels greater than 170 µmol/l or estimated glomerular filtration rate (eGFR) < 30 ml/min.
History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome).
History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).
Known or suspected secondary hypertension.
Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.
Pregnancy or those of child-bearing age who are not taking reliable contraception.
Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with angiotensin converting enzyme inhibitors.
Patients on maximum dose of any of the study medications as monotherapy (i.e. amlodipine 10 mg/day or hydrochlorothiazide 25 mg/day or perindopril 8 mg/day)
Gout.
Serum potassium < 3.5mmol/L at screening.

Sites / Locations

University of Abuja Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Perindopril plus Amlodipine at a dose of 4mg/5mg once daily for two months and 8mg/10mg once daily for the remaining four months.

Perindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months.

Amlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months.

Outcomes

Primary Outcome Measures

Ambulatory blood pressure

Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined.

Secondary Outcome Measures

Assessment of ambulatory diastolic blood pressure

Change in 24 hour ambulatory diastolic blood pressure between randomisation and 6 months

Clinic systolic and diastolic blood pressure

Change in clinic systolic and diastolic blood pressure will be difference in values between randomisation and 6 months

Night time and day time blood pressure

Change in daytime and night time blood pressure

Blood pressure control

change in BP variability measured will be measured by ambulatory blood pressure

Blood pressure control

Proportion of patients who achieve BP control (defined as clinic BP < 140/90 mmHg) after 6 months

Response to study medications

Proportion of "responders" (defined as clinic BP reduction > 20mmHg SBP and >10 mmHg DBP) from randomisation to 6 months

Change in values of micro- and macro-albuminuria

Change in micro- and macro-albuminuria will be measured from randomisation to 6 months

Fasting blood sugar variation

Change in fasting blood sugar which will be from randomisation to 6 months

Fasting lipid profile variation

Change in fasting lipid profile between from randomisation to 6 months

Full Information

NCT ID

NCT02742467

First Posted

April 14, 2016

Last Updated

August 17, 2021

Sponsor

University of Abuja

Collaborators

Imperial College London, University of Cape Town, Hôpital Edouard Herriot, University of Nairobi, University College Hospital, Ibadan, Hospital General De Douala, Mulago Hospital, Uganda

1. Study Identification

Unique Protocol Identification Number

NCT02742467

Brief Title

Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans

Acronym

Creole

Official Title

Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

June 7, 2017 (Actual)

Primary Completion Date

June 1, 2018 (Actual)

Study Completion Date

June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Abuja

Collaborators

Imperial College London, University of Cape Town, Hôpital Edouard Herriot, University of Nairobi, University College Hospital, Ibadan, Hospital General De Douala, Mulago Hospital, Uganda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The creole study is a A Multi-centre, multinational, randomised single-blind, parallel group, three-armed superiority trial which is aimed at comparing the efficacy of three "free" combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure (ASBP) in black African hypertensive patients.

Detailed Description

The CREOLE trial will be performed at ten investigational sites in six countries in Sub-Saharan Africa which include Cameroun, Kenya, Mozambique, Nigeria, South Africa and Uganda. Subjects will be randomised to one of three treatments which are Perindopril plus Amlodipine or Perindopril plus Hydrochlorothiazide or Amlodipine plus Hydrochlorothiazide.Patients will commence treatment at a starting dose of Amlodipine plus Hydrochlorothiazide 5/12.5 mg or Amlodipine plus Perindopril 5/4 mg or Perindopril/Hydrochlorothiazide 4/12.5 mg. These doses will increase at the two months visit, to Amlodipine/Hydrochlorothiazide 10/25 mg or AmlodipinePperindopril 10/8mg or Perindopril/Hydrochlorothiazide 8/25 mg. The patients will have ambulatory blood pressure monitoring at randomization and at six months and office blood pressure measurements at randomization and at two-month, 4-month and six-month visits.The overall aim is to discover the best combination of front-line anti-hypertensive medications for black patients residing in sub-Saharan Africa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

702 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Perindopril plus Amlodipine at a dose of 4mg/5mg once daily for two months and 8mg/10mg once daily for the remaining four months.

Arm Title

Arm Type

Active Comparator

Arm Description

Perindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months.

Arm Title

Arm Type

Active Comparator

Arm Description

Amlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months.

Intervention Type

Drug

Intervention Name(s)

Perindopril plus Amlodipine

Intervention Description

Group 1

Intervention Type

Drug

Intervention Name(s)

Perindopril plus Hydrochlorothiazide

Intervention Description

Group 2

Intervention Type

Drug

Intervention Name(s)

Amlodipine plus Hydrochlorothiazide

Intervention Description

Group 3

Primary Outcome Measure Information:

Title

Ambulatory blood pressure

Description

Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined.

Time Frame

six months

Secondary Outcome Measure Information:

Title

Assessment of ambulatory diastolic blood pressure

Description

Change in 24 hour ambulatory diastolic blood pressure between randomisation and 6 months

Time Frame

six months

Title

Clinic systolic and diastolic blood pressure

Description

Change in clinic systolic and diastolic blood pressure will be difference in values between randomisation and 6 months

Time Frame

Six months

Title

Night time and day time blood pressure

Description

Change in daytime and night time blood pressure

Time Frame

Six months

Title

Blood pressure control

Description

change in BP variability measured will be measured by ambulatory blood pressure

Time Frame

Six months

Title

Blood pressure control

Description

Proportion of patients who achieve BP control (defined as clinic BP < 140/90 mmHg) after 6 months

Time Frame

Two months and six months

Title

Response to study medications

Description

Proportion of "responders" (defined as clinic BP reduction > 20mmHg SBP and >10 mmHg DBP) from randomisation to 6 months

Time Frame

Two months and six months

Title

Change in values of micro- and macro-albuminuria

Description

Change in micro- and macro-albuminuria will be measured from randomisation to 6 months

Time Frame

Six months

Title

Fasting blood sugar variation

Description

Change in fasting blood sugar which will be from randomisation to 6 months

Time Frame

Six months

Title

Fasting lipid profile variation

Description

Change in fasting lipid profile between from randomisation to 6 months

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with Sitting SBP ≥140 mm Hg and < 160 mmHg on one antihypertensive agen or Sitting SBP ≥ 150 mm Hg and < 180 mm Hg on no antihypertensive treatment. Exclusion Criteria: Congestive heart failure (clinically defined). Serum creatinine levels greater than 170 µmol/l or estimated glomerular filtration rate (eGFR) < 30 ml/min. History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome). History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit). Known or suspected secondary hypertension. Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study. Pregnancy or those of child-bearing age who are not taking reliable contraception. Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with angiotensin converting enzyme inhibitors. Patients on maximum dose of any of the study medications as monotherapy (i.e. amlodipine 10 mg/day or hydrochlorothiazide 25 mg/day or perindopril 8 mg/day) Gout. Serum potassium < 3.5mmol/L at screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Poulter, MD, MSc

Organizational Affiliation

Imperial College London

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bongani Mayosi, DPhil

Organizational Affiliation

University of Cape Town

Official's Role

Study Chair

Facility Information:

Facility Name

University of Abuja Teaching Hospital

City

Abuja

State/Province

Federal Capital Territory

ZIP/Postal Code

90001

Country

Nigeria

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

34022790

Citation

Ingabire PM, Ojji DB, Rayner B, Ogola E, Damasceno A, Jones E, Dzudie A, Ogah OS, Poulter N, Sani MU, Barasa FA, Shedul G, Mukisa J, Mukunya D, Wandera B, Batte C, Kayima J, Pandie S, Mondo CK; CREOLE Study Investigators. High prevalence of non-dipping patterns among Black Africans with uncontrolled hypertension: a secondary analysis of the CREOLE trial. BMC Cardiovasc Disord. 2021 May 22;21(1):254. doi: 10.1186/s12872-021-02074-7.

Results Reference

derived

PubMed Identifier

30883050

Citation

Ojji DB, Mayosi B, Francis V, Badri M, Cornelius V, Smythe W, Kramer N, Barasa F, Damasceno A, Dzudie A, Jones E, Mondo C, Ogah O, Ogola E, Sani MU, Shedul GL, Shedul G, Rayner B, Okpechi IG, Sliwa K, Poulter N; CREOLE Study Investigators. Comparison of Dual Therapies for Lowering Blood Pressure in Black Africans. N Engl J Med. 2019 Jun 20;380(25):2429-2439. doi: 10.1056/NEJMoa1901113. Epub 2019 Mar 18.

Results Reference

derived

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Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans

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