Clinical trial NCT03747978: Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide in Type 2 Diabetes
Official title: Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: diabetes
hypertension
blacks
Africa
ACE inhibitor
Calcium channel blocker
Diuretic
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Yaounde 1
First posted: 2018-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind head to head trial
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 24-hour blood pressure
timeFrame: 6 weeks
Secondary outcomes:
measure: night blood pressure dip
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: National Obesity Centre, Yaounde Central Hospital
state: Centre
Study officials:
affiliation: Yaounde Central Hospital
name: Eugene Sobngwi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sobngwi E, Mfeukeu-Kuate L, Kouam M, Tankeu AT, Nganou-Gnindjio CN, Hamadou B, Etoa M, Ngassam E, Nkamgna A, Dehayem MY, Kaze FF, Kengne AP, Mbanya JC. Short-term effects of perindopril-amlodipine vs perindopril-indapamide on blood pressure control in sub-Saharan type 2 diabetic individuals newly diagnosed for hypertension: A double-blinded randomized controlled trial. J Clin Hypertens (Greenwich). 2019 Jul;21(7):1002-1008. doi: 10.1111/jch.13557. Epub 2019 Jun 8.