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

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ClinicalTrials.gov Identifier: NCT03747978
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
University of Yaounde 1
Information provided by (Responsible Party):
Sobngwi Eugene, Yaounde Central Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hypertension Drug: Perindopril and Amlodipine Drug: Perindopril-indapamide Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind head to head trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017


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 Name: 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 Name: Bipreterax5/1.25




Primary Outcome Measures :
  1. 24-hour blood pressure [ Time Frame: 6 weeks ]
    Change in average 24-hour blood pressure


Secondary Outcome Measures :
  1. night blood pressure dip [ Time Frame: 6 weeks ]
    Change in average night time blood pressure drop



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747978


Locations
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Cameroon
National Obesity Centre, Yaounde Central Hospital
Yaounde, Centre, Cameroon
Sponsors and Collaborators
Yaounde Central Hospital
University of Yaounde 1
Investigators
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Principal Investigator: Eugene Sobngwi, MD, PhD Yaounde Central Hospital

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Responsible Party: Sobngwi Eugene, Medical Advisor, Yaounde Central Hospital
ClinicalTrials.gov Identifier: NCT03747978     History of Changes
Other Study ID Numbers: CNO20164
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sobngwi Eugene, Yaounde Central Hospital:
diabetes
hypertension
blacks
Africa
ACE inhibitor
Calcium channel blocker
Diuretic
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Perindopril
Indapamide
Indapamide, perindopril drug combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors