NCT03747978

Brief Summary

This was a double-blinded randomized controlled trial of 24-hour blood pressure control in sub Saharan type 2 diabetes patients, newly diagnosed for hypertension. They were allocated to receive either a fixed combination of perindopril + amlodipine or perindopril + indapamide for 42 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

November 18, 2018

Last Update Submit

November 18, 2018

Conditions

Diabetes Mellitus, Type 2Hypertension

Keywords

diabeteshypertensionblacksAfricaACE inhibitorCalcium channel blockerDiuretic

Outcome Measures

Primary Outcomes (1)

  • 24-hour blood pressure

    Change in average 24-hour blood pressure

    6 weeks

Secondary Outcomes (1)

  • night blood pressure dip

    6 weeks

Study Arms (2)

Perindopril and Amlodipine

EXPERIMENTAL

Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks

Drug: Perindopril and Amlodipine

Perindopril-Indapamide

ACTIVE COMPARATOR

Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks

Drug: Perindopril-indapamide

Interventions

Perindopril and AmlodipineDRUG

Fixed combination of Perindopril 5mg and Amlodipine 5mg

Also known as: Coveram5/5mg
Perindopril and Amlodipine
Perindopril-indapamideDRUG

Perindopril 5mg and Indapamide 1.25mg

Also known as: Bipreterax5/1.25
Perindopril-Indapamide

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult diabetes patients aged between 25-65 years,
  • with grade I or grade II (WHO classification) hypertension on the clinical measure, confirmed by ABPM
  • naïve to any anti-hypertensive treatment
  • written informed consent.

You may not qualify if:

  • Patients with grade III hypertension (WHO classification) were classified as hypertensive emergency,
  • estimated creatinine clearance ˂30ml/min/1.73m2 (using Modified Diet in Renal Diseases formula)
  • alanine transaminase (ALT)≥ 3 normal
  • any contraindication to study drugs (hypersensitivity)
  • pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Location

Related Publications (1)

  • Sobngwi E, Mfeukeu-Kuate L, Kouam M, Tankeu AT, Nganou-Gnindjio CN, Hamadou B, Etoa M, Ngassam E, Nkamgna A, Dehayem MY, Kaze FF, Kengne AP, Mbanya JC. Short-term effects of perindopril-amlodipine vs perindopril-indapamide on blood pressure control in sub-Saharan type 2 diabetic individuals newly diagnosed for hypertension: A double-blinded randomized controlled trial. J Clin Hypertens (Greenwich). 2019 Jul;21(7):1002-1008. doi: 10.1111/jch.13557. Epub 2019 Jun 8.

    PMID: 31175711DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionDiabetes Mellitus

Interventions

amlodipine, perindopril drug combinationindapamide, perindopril drug combination

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Eugene Sobngwi, MD, PhD

    Yaounde Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double blind head to head trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Advisor

Study Record Dates

First Submitted

November 18, 2018

First Posted

November 20, 2018

Study Start

October 1, 2016

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations

CA(1)