NCT03747978

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Yaounde Central Hospital · Other Government
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 2
• Hypertension

Interventions

Type	Name	Description
DRUG	Perindopril and Amlodipine	Fixed combination of Perindopril 5mg and Amlodipine 5mg
DRUG	Perindopril-indapamide	Perindopril 5mg and Indapamide 1.25mg

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-05-30
• Completion: 2017-05-30
• First posted: 2018-11-20
• Last updated: 2018-11-20

Locations

1 site across 1 country: Cameroon