NCT03393715

Brief Summary

We assessed the influence of time of administration of ACE inhibitors on circadian blood pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56 days as first line treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

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

Timeline
Completed

Started Feb 2016

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

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

February 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

December 21, 2017

Last Update Submit

January 5, 2018

Conditions

Diabetes Mellitus, Type 2Hypertension

Keywords

DiabetesHypertensionPerindoprilchronobiologyAfrica

Outcome Measures

Primary Outcomes (1)

  • 24-hour blood pressure profile

    Overall blood pressure control

    56 days

Secondary Outcomes (1)

  • Night time blood pressure dip

    56 days

Study Arms (2)

Perindopril morning

EXPERIMENTAL

10 mg of perindopril oral tablet once daily in the morning for 56 days

Drug: Perindopril Oral Tablet

Perindopril evening

ACTIVE COMPARATOR

10 mg of perindopril oral tablet once daily in the evening for 56 days

Drug: Perindopril Oral Tablet

Interventions

Perindopril Oral TabletDRUG

Perindopril oral tablet morning versus evening

Also known as: Coversyl 10 mg
Perindopril eveningPerindopril morning

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Grade 1 hypertension
  • Informed consent

You may not qualify if:

  • estimated creatinine clearance≤ 60ml/min
  • White coat hypertension after initial 24 hour ABPM
  • Previous antihypertensive treatment
  • Pregnant women
  • Individuals working during the night
  • Hyperkalemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionDiabetes Mellitus

Interventions

Perindopril

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Eugène Sobngwi, MD, PhD

    Yaounde Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: open label randomised controlled trial with crossover of perindopril administered in the morning versus evening on blood pressure control
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology and Diabetes

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 8, 2018

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

January 8, 2018

Record last verified: 2018-01