Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes (CHRONIC1)

January 5, 2018 updated by: Sobngwi Eugene, Yaounde Central Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life and offer the advantage of a single daily dose, usually empirically taken in the morning.

Objective: We assessed the influence of time of administration of ACE inhibitors on circadian BP control in type 2 diabetes (T2D) patients with stage 1 hypertension.

Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with stage 1 of hypertension and naive to BP lowering medications, were included. They were randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or in the evening for 28 days, with crossover without washout period on day 29th and additional 28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days 28 and 56.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Grade 1 hypertension
  • Informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perindopril morning
10 mg of perindopril oral tablet once daily in the morning for 56 days
Drug: Perindopril Oral Tablet
Perindopril oral tablet morning versus evening
Other Names:
  • Coversyl 10 mg
Active Comparator: Perindopril evening
10 mg of perindopril oral tablet once daily in the evening for 56 days
Drug: Perindopril Oral Tablet
Perindopril oral tablet morning versus evening
Other Names:
  • Coversyl 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour blood pressure profile
Time Frame: 56 days
Overall blood pressure control
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Night time blood pressure dip
Time Frame: 56 days
Blood pressure drop at night
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yaounde Central Hospital

Collaborators

University of Yaounde 1

Investigators

  • Principal Investigator: Eugène Sobngwi, MD, PhD, Yaoundé Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNO20162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Perindopril Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe