Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide in Type 2 Diabetes
Overview
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.
Full Title of Study: “Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 30, 2017
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
- Drug: Perindopril and Amlodipine
- Fixed combination of Perindopril 5mg and Amlodipine 5mg
- Drug: Perindopril-indapamide
- Perindopril 5mg and Indapamide 1.25mg
Arms, Groups and Cohorts
- Experimental: Perindopril and Amlodipine
- Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks
- Active Comparator: Perindopril-Indapamide
- Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks
Clinical Trial Outcome Measures
Primary Measures
- 24-hour blood pressure
- Time Frame: 6 weeks
- Change in average 24-hour blood pressure
Secondary Measures
- night blood pressure dip
- Time Frame: 6 weeks
- Change in average night time blood pressure drop
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 25 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Yaounde Central Hospital
- Collaborator
- University of Yaounde 1
- Provider of Information About this Clinical Study
- Principal Investigator: Sobngwi Eugene, Medical Advisor – Yaounde Central Hospital
- Overall Official(s)
- Eugene Sobngwi, MD, PhD, Principal Investigator, Yaounde Central Hospital
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