HypertensionPhase 4CreoleNCT02742467

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

A Phase 4 study testing Perindopril plus Amlodipine, Perindopril plus Hydrochlorothiazide and Amlodipine plus Hydrochlorothiazide in people with Hypertension, run by University of Abuja at 1 site in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 to 79 years
Conditions the study is for: Hypertension
What is being tested?: Perindopril plus Amlodipine, Perindopril plus Hydrochlorothiazide and Amlodipine plus Hydrochlorothiazide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 702 participants
Where: 1 siteNigeria
Study dates: 7 Jun 2017to 1 Jun 2018
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Nigeria1 site

University of Abuja Teaching Hospital
Abuja, Federal Capital Territory, 90001

Other trials in Nigeria

About this study

Read the 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.

Conditions: Hypertension
Being tested: Perindopril plus Amlodipine, Perindopril plus Hydrochlorothiazide, Amlodipine plus Hydrochlorothiazide
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Perindopril plus AmlodipineDrug
Group 1
Perindopril plus HydrochlorothiazideDrug
Group 2
Amlodipine plus HydrochlorothiazideDrug
Group 3

Study groups in NCT02742467
Study group	Role	What they receive
1	Experimental	Perindopril plus Amlodipine at a dose of 4mg/5mg once daily for two months and 8mg/10mg once daily for the remaining four months. Receives: Drug: Perindopril plus Hydrochlorothiazide; Drug: Amlodipine plus Hydrochlorothiazide
2	Active comparator	Perindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months. Receives: Drug: Perindopril plus Amlodipine; Drug: Amlodipine plus Hydrochlorothiazide
3	Active comparator	Amlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months. Receives: Drug: Perindopril plus Amlodipine; Drug: Perindopril plus Hydrochlorothiazide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

Assessment of ambulatory diastolic blood pressure
Change in 24 hour ambulatory diastolic blood pressure between randomisation and 6 months
Measured: six 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
Measured: Six months
Night time and day time blood pressure
Change in daytime and night time blood pressure
Measured: Six months
Blood pressure control
change in BP variability measured will be measured by ambulatory blood pressure
Measured: Six months
Blood pressure control
Proportion of patients who achieve BP control (defined as clinic BP < 140/90 mmHg) after 6 months
Measured: Two months and six months
Response to study medications
Proportion of "responders" (defined as clinic BP reduction > 20mmHg SBP and >10 mmHg DBP) from randomisation to 6 months
Measured: Two months and six months
Change in values of micro- and macro-albuminuria
Change in micro- and macro-albuminuria will be measured from randomisation to 6 months
Measured: Six months
Fasting blood sugar variation
Change in fasting blood sugar which will be from randomisation to 6 months
Measured: Six months
Fasting lipid profile variation
Change in fasting lipid profile between from randomisation to 6 months
Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 20171 Jun 2018

First posted19 Apr 2016 (estimated)
Study start7 Jun 2017
Primary completion1 Jun 2018
Study completion1 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 702 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02742467
Sponsor's protocol ID: Project8264
Acronym: Creole
Status last verified: Aug 2021
First submitted: 14 Apr 2016
Last updated: 24 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

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.
PubMed 34022790
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.
PubMed 30883050

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans
ClinicalTrials.gov ID: NCT02742467
Acronym / sponsor ID: Creole / Project8264
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 702 participants (actual)
Lead sponsor: University of AbujaUniversity, hospital or other
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
Study start: 7 Jun 2017 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 1 Jun 2018 (actual)
First posted: 19 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Perindopril plus Hydrochlorothiazide, Drug: Amlodipine plus HydrochlorothiazidePerindopril plus Amlodipine at a dose of 4mg/5mg once daily for two months and 8mg/10mg once daily for the remaining four months.
2	Active comparator	Drug: Perindopril plus Amlodipine, Drug: Amlodipine plus HydrochlorothiazidePerindopril Plus Hydrochlorothiazide at a dose of 4mg/12.5mg and 8mg/25mg once daily for the remaining four months.
3	Active comparator	Drug: Perindopril plus Amlodipine, Drug: Perindopril plus HydrochlorothiazideAmlodipine plus Hydrochlorothiazide 5mg/12.5mg for two months and 10mg/25mg for the remaining four months.

Who may qualify

Ages: 30 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Perindopril plus AmlodipineGroup 1	Drug	2, 3
Perindopril plus HydrochlorothiazideGroup 2	Drug	1, 3
Amlodipine plus HydrochlorothiazideGroup 3	Drug	1, 2

Primary outcome

Ambulatory blood pressure
Time frame: six months
Change in ambulatory systolic blood pressure measurement from baseline to 6 months from will be determined.

9 secondary outcomes

Assessment of ambulatory diastolic blood pressure
Time frame: six months
Clinic systolic and diastolic blood pressure
Time frame: Six months
Night time and day time blood pressure
Time frame: Six months
Blood pressure control
Time frame: Six months
Blood pressure control
Time frame: Two months and six months
Response to study medications
Time frame: Two months and six months
Change in values of micro- and macro-albuminuria
Time frame: Six months
Fasting blood sugar variation
Time frame: Six months
Fasting lipid profile variation
Time frame: Six months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
Derived from this study: PubMed 34022790Ingabire 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.
Derived from this study: PubMed 30883050Ojji 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.
Individual participant dataSharing planned: Yes

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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neil Poulter, MD, MSc study director

Imperial College London

Bongani Mayosi, DPhil study chair

University of Cape Town

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ambulatory blood pressure (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02742467, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.