Diabetes Mellitus, Type 2Phase 4CHRONIC1NCT03393715
Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes
A Phase 4 study testing Perindopril Oral Tablet in people with Diabetes Mellitus, Type 2 and Hypertension, run by Yaounde Central Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Perindopril Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Grade 1 hypertension
- Informed consent
Who cannot join
- estimated creatinine clearance≤ 60ml/min
- White coat hypertension after initial 24 hour ABPM
- Previous antihypertensive treatment
- Pregnant women
- Individuals working during the night
- Hyperkalemia
About this study
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.
Read the detailed 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.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Perindopril Oral Tablet
- Keywords
- Diabetes, Hypertension, Perindopril, chronobiology, Africa
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perindopril Oral TabletDrug
Also called Coversyl 10 mg
Perindopril oral tablet morning versus evening
| Study group | Role | What they receive |
|---|---|---|
| Perindopril morning | Experimental | 10 mg of perindopril oral tablet once daily in the morning for 56 days Receives: Drug: Perindopril Oral Tablet |
| Perindopril evening | Active comparator | 10 mg of perindopril oral tablet once daily in the evening for 56 days Receives: Drug: Perindopril Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour blood pressure profile
Overall blood pressure control
Measured: 56 days
Secondary outcomes (1)
Night time blood pressure dip
Blood pressure drop at night
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study startFeb 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- open label randomised controlled trial with crossover of perindopril administered in the morning versus evening on blood pressure control
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Collaborators
- University of Yaounde 1
- Responsible party
- Principal investigator, Sobngwi Eugene, Yaounde Central Hospital
- Investigators
- Eugène Sobngwi, MD, PhD, Principal investigator, Yaounde Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393715
- Sponsor's protocol ID
- CNO20162
- Acronym
- CHRONIC1
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03393715
- Acronym / sponsor ID
- CHRONIC1 / CNO20162
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- Diabetes, Hypertension, Perindopril, chronobiology, Africa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Collaborators
- University of Yaounde 1
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label randomised controlled trial with crossover of perindopril administered in the morning versus evening on blood pressure control
| Arm | Type | Receives |
|---|---|---|
| Perindopril morning | Experimental | Drug: Perindopril Oral Tablet10 mg of perindopril oral tablet once daily in the morning for 56 days |
| Perindopril evening | Active comparator | Drug: Perindopril Oral Tablet10 mg of perindopril oral tablet once daily in the evening for 56 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- Grade 1 hypertension
- Informed consent
Key exclusion criteria (6 listed)
- estimated creatinine clearance≤ 60ml/min
- White coat hypertension after initial 24 hour ABPM
- Previous antihypertensive treatment
- Pregnant women
- Individuals working during the night
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perindopril Oral TabletAlso: Coversyl 10 mgPerindopril oral tablet morning versus evening | Drug | Perindopril evening, Perindopril morning |
Primary outcome
24-hour blood pressure profile
Time frame: 56 days
Overall blood pressure control
1 secondary outcome
Night time blood pressure dip
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugène Sobngwi, MD, PhD principal investigator
Yaounde Central Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perindopril Oral Tablet in people with Diabetes Mellitus, Type 2 and Hypertension, run by Yaounde Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour blood pressure profile (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.