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

NCT02742467 | Completed Phase 4 DMC

• 1 other identifier: Project8264
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Ambulatory blood pressure

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

  six months

Secondary Outcomes (9)

• Assessment of ambulatory diastolic blood pressure

  six months

• Clinic systolic and diastolic blood pressure

  Six months

• Night time and day time blood pressure

  Six months

• Blood pressure control

  Six months

• Blood pressure control

  Two months and six months

Study Arms (3)

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.

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.

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.

Drug: Perindopril plus Amlodipine; Drug: Perindopril plus Hydrochlorothiazide

Interventions

Perindopril plus Amlodipine DRUG

Group 1

2; 3

Perindopril plus Hydrochlorothiazide DRUG

Group 2

1; 3

Amlodipine plus Hydrochlorothiazide DRUG

Group 3

1; 2

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Abuja: lead
• Imperial College London: collaborator
• University of Cape Town: collaborator
• Hôpital Edouard Herriot: collaborator
• University of Nairobi: collaborator
• University College Hospital, Ibadan: collaborator
• Hospital General De Douala: collaborator
• Mulago Hospital, Uganda: collaborator

Study Sites (1)

University of Abuja Teaching Hospital

Abuja, Federal Capital Territory, 90001, Nigeria

Location

Related Publications (2)

• 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.

  PMID: 34022790 DERIVED

• 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.

  PMID: 30883050 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Perindopril; Amlodipine; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides

Study Officials

• Neil Poulter, MD, MSc

  Imperial College London

  STUDY DIRECTOR

• Bongani Mayosi, DPhil

  University of Cape Town

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: June 7, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

NG (1)