Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide in Type 2 Diabetes

November 18, 2018 updated by: Sobngwi Eugene, Yaounde Central Hospital

Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a double-blinded randomized controlled trial conducted at the National Obesity Center and the cardiology unit of the Yaoundé Central Hospital in Cameroon from October 2016 to May 2017. Eligible patients were type 2 diabetes patients, newly diagnosed for hypertension (grade I or II) with confirmation on ambulatory BP monitoring (ABPM). Patients were either on lifestyle modification alone or on a stable anti-diabetic treatment for the past three months, aged 25-65 years naïve to any anti-hypertensive treatment, who provided their written informed consent. Participants were assigned to receive as anti-hypertensive treatment perindopril-amlodipine once daily or perindopril-indapamide at the same frequency. The two groups were followed up and monitored for sixth weeks and patients did not take any additional treatment with BP modifying properties.

The primary outcome was the relative change in circadian blood pressure profile between the two groups after six weeks of treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
    • Centre
      • Yaounde, Centre, Cameroon
        • National Obesity Centre, Yaounde Central Hospital

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

23 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perindopril and Amlodipine
Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks
Drug: Perindopril and Amlodipine
Fixed combination of Perindopril 5mg and Amlodipine 5mg
Other Names:
  • Coveram5/5mg
Active Comparator: Perindopril-Indapamide
Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks
Drug: Perindopril-indapamide
Perindopril 5mg and Indapamide 1.25mg
Other Names:
  • Bipreterax5/1.25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour blood pressure
Time Frame: 6 weeks
Change in average 24-hour blood pressure
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
night blood pressure dip
Time Frame: 6 weeks
Change in average night time blood pressure drop
6 weeks

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2016

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

November 18, 2018

First Submitted That Met QC Criteria

November 18, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 18, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNO20164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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