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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-05-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Diabetes Mellitus, Type 2 Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind head to head trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Perindopril and Amlodipine

Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks

Group Type EXPERIMENTAL

Perindopril and Amlodipine

Intervention Type DRUG

Fixed combination of Perindopril 5mg and Amlodipine 5mg

Perindopril-Indapamide

Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks

Group Type ACTIVE_COMPARATOR

Perindopril-indapamide

Intervention Type DRUG

Perindopril 5mg and Indapamide 1.25mg

Interventions

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Perindopril and Amlodipine

Fixed combination of Perindopril 5mg and Amlodipine 5mg

Intervention Type DRUG

Perindopril-indapamide

Perindopril 5mg and Indapamide 1.25mg

Intervention Type DRUG

Other Intervention Names

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Coveram5/5mg Bipreterax5/1.25

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No