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Completed

NCT Number: NCT03747978

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perindopril and Amlodipine

Drug

Fixed combination of Perindopril 5mg and Amlodipine 5mg

Other names: Coveram5/5mg

Perindopril-indapamide

Drug

Perindopril 5mg and Indapamide 1.25mg

Other names: Bipreterax5/1.25

Primary outcomes

  1. 24-hour blood pressure

    Time frame: 6 weeks

    Change in average 24-hour blood pressure

Secondary outcomes

  1. night blood pressure dip

    Time frame: 6 weeks

    Change in average night time blood pressure drop

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Collaborators

  • University of Yaounde 1

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2018
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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