Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes

Hypertension Clinical Trial

— CHRONIC1  

Official title:

Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393715
• Other study ID #: CNO20162
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2017
• Last updated: January 5, 2018
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: January 2018
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We assessed the influence of time of administration of ACE inhibitors on circadian blood pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56 days as first line treatment.

Description:

Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life and offer the advantage of a single daily dose, usually empirically taken in the morning.

Objective: We assessed the influence of time of administration of ACE inhibitors on circadian BP control in type 2 diabetes (T2D) patients with stage 1 hypertension.

Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with stage 1 of hypertension and naive to BP lowering medications, were included. They were randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or in the evening for 28 days, with crossover without washout period on day 29th and additional 28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days 28 and 56.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Grade 1 hypertension

• Informed consent

Exclusion Criteria:

• estimated creatinine clearance= 60ml/min

• White coat hypertension after initial 24 hour ABPM

• Previous antihypertensive treatment

• Pregnant women

• Individuals working during the night

• Hyperkalemia

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Drug:
• Perindopril Oral Tablet
Perindopril oral tablet morning versus evening

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yaounde Central Hospital	University of Yaounde 1

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour blood pressure profile	Overall blood pressure control	56 days
Secondary	Night time blood pressure dip	Blood pressure drop at night	56 days