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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03747978

Enrollment

Registered

2018-11-20

Start date

2016-10-01

Completion date

2017-05-30

Last updated

2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Hypertension

Keywords

diabetes, hypertension, blacks, Africa, ACE inhibitor, Calcium channel blocker, Diuretic

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

Interventions

DRUGPerindopril and Amlodipine

Fixed combination of Perindopril 5mg and Amlodipine 5mg

DRUGPerindopril-indapamide

Perindopril 5mg and Indapamide 1.25mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

double blind head to head trial

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
24-hour blood pressure	6 weeks	Change in average 24-hour blood pressure

Secondary

Measure	Time frame	Description
night blood pressure dip	6 weeks	Change in average night time blood pressure drop

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026