Diabetes Mellitus, Type 2Phase 4NCT03747978
Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide in Type 2 Diabetes
A Phase 4 study testing Perindopril and Amlodipine and Perindopril-indapamide in people with Diabetes Mellitus, Type 2 and Hypertension, run by Yaounde Central Hospital at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Perindopril and Amlodipine and Perindopril-indapamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Oct 2016to 30 May 2017
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
National Obesity Centre, Yaounde Central Hospital
Yaoundé, Centre Region
About this study
Official title: Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Perindopril and Amlodipine, Perindopril-indapamide
- Keywords
- diabetes, hypertension, blacks, Africa, ACE inhibitor, Calcium channel blocker, Diuretic
- 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 and AmlodipineDrug
Also called Coveram5/5mg
Fixed combination of Perindopril 5mg and Amlodipine 5mg
Perindopril-indapamideDrug
Also called Bipreterax5/1.25
Perindopril 5mg and Indapamide 1.25mg
| Study group | Role | What they receive |
|---|---|---|
| Perindopril and Amlodipine | Experimental | Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks Receives: Drug: Perindopril and Amlodipine |
| Perindopril-Indapamide | Active comparator | Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks Receives: Drug: Perindopril-indapamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour blood pressure
Change in average 24-hour blood pressure
Measured: 6 weeks
Secondary outcomes (1)
night blood pressure dip
Change in average night time blood pressure drop
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Oct 2016
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- double blind head to head trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- Eugene Sobngwi, MD, PhD, Principal investigator, Yaounde Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747978
- Sponsor's protocol ID
- CNO20164
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31175711
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension
- ClinicalTrials.gov ID
- NCT03747978
- Acronym / sponsor ID
- CNO20164
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- diabetes, hypertension, blacks, Africa, ACE inhibitor, Calcium channel blocker, Diuretic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Collaborators
- University of Yaounde 1
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 20 Nov 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind head to head trial
| Arm | Type | Receives |
|---|---|---|
| Perindopril and Amlodipine | Experimental | Drug: Perindopril and AmlodipineFixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks |
| Perindopril-Indapamide | Active comparator | Drug: Perindopril-indapamideFixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 and AmlodipineAlso: Coveram5/5mgFixed combination of Perindopril 5mg and Amlodipine 5mg | Drug | Perindopril and Amlodipine |
| Perindopril-indapamideAlso: Bipreterax5/1.25Perindopril 5mg and Indapamide 1.25mg | Drug | Perindopril-Indapamide |
Primary outcome
24-hour blood pressure
Time frame: 6 weeks
Change in average 24-hour blood pressure
1 secondary outcome
night blood pressure dip
Time frame: 6 weeks
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 20 Nov 2018.
- Derived from this study: PubMed 31175711Sobngwi 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.
- Individual participant dataSharing planned: Undecided
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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.
Eugene Sobngwi, MD, PhD principal investigator
Yaounde Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perindopril and Amlodipine and Perindopril-indapamide in people with Diabetes Mellitus, Type 2 and Hypertension, run by Yaounde Central Hospital at 1 site in Cameroon.
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 4 inclusion and 5 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747978, which also lists 1 linked publication.
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 20 Nov 2018.