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

Phase 4

Completed

• Conditions: Hypertension; Diabetes Mellitus, Type 2
• Interventions: Drug: Perindopril-indapamide; Drug: Perindopril and Amlodipine

• Registration Number: NCT03747978
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-18
• Study First Submitted QC: 2018-11-18
• Last Update Submitted: 2018-11-18
• Study First Posted: 2018-11-20
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perindopril-Indapamide	Perindopril-indapamide	Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks
Perindopril and Amlodipine	Perindopril and Amlodipine	Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
24-hour blood pressure	6 weeks	Change in average 24-hour blood pressure

Secondary Outcome Measures

Name	Time	Method
night blood pressure dip	6 weeks	Change in average night time blood pressure drop

Trial Locations

Locations (1)

National Obesity Centre, Yaounde Central Hospital; 🇨🇲 Yaounde, Centre, Cameroon