Type 2 Diabetes MellitusPhase 4CARE-PLPNCT04222686
Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients
A Phase 4 study testing Perindopril Arginine and Losartan Potassium in people with Type 2 Diabetes Mellitus, run by Yaounde Central Hospital at 1 site in Cameroon.
Trial summary
The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Perindopril Arginine and Losartan Potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCameroon
- Study dates
- 20 Dec 2017to 30 Apr 2018
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetics subjects
- Urinary albumin excretion >30 g/day or Blood pressure > 140/90
- On a stable antidiabetic and antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. The pharmacological treatment should not include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker
- Subject must not present any contraindication to exercise
- Before any study-specific procedure, the appropriate written informed consent must be obtained.
Who cannot join
- Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
- Signs of exercise intolerance
- Out of sight.
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rationale and Design of a Simple Randomized Trial Evaluating Losartan and Perindopril in Blacks Type 2 Diabetics Patients: the Cardiac and Renal Protection With Losartan or Perindopril (CARE-PLP) Trial
The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.
Read the detailed description
Given the particularity of the renin-angiotensin system in black subjects, the CARE-PLP study fulfills this objective with the comparison of Losartan and Perindopril after 08 weeks of administration in a subsaharan African population.
Aim: The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients
Methods: CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.
Progress: Recruitment for CARE-PLP was completed in february 2018 with 29 patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Perindopril Arginine, Losartan Potassium
- Keywords
- Angiotensin Converting Enzymes Inhibitor, Angiotensin II Receptor Blockers, Type 2 Diabetes, Exercise induced urinary albumin excretion, Blood pressure
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perindopril ArginineDrug
Also called Perindopril
10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
Losartan PotassiumDrug
Also called Losartan
100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Perindopril Arm | Active comparator | 10 mg Perindopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks. Receives: Drug: Perindopril Arginine |
| Losartan Arm | Active comparator | 100 mg Losartan tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks. Receives: Drug: Losartan Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of exercise-induced urinary albumin excretion
Variation of exercise-induced urinary albumin excretion (mg/j) between week 0 and week 8. By nephelometry method.
Measured: 8 weeks
Secondary outcomes (6)
Change in rest urinary albumin excretion
Change in rest urinary albumin excretion (mg/l) from baseline to week 08. By nephelometry method.
Measured: 8 weeks
Change in mitral E/Ea ratio
Change in mitral E/Ea ratio from baseline to week 08. By tissue doppler on echocardiography.
Measured: 8 weeks
Change in nycthemeral blood pressure profile (mmHg)
Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.
Measured: 8 weeks
Change in concentration of antioxidants markers (micromol)
Change in concentration of antioxidants markers from baseline to week 08. By spectrophotometer
Measured: 8 weeks
Change in lipid profile (triglycerides, Total cholesterol, HDL-cholesterol, LDL-cholesterol) on g/l
Change in lipid profile from baseline to week 08. By spectrophotometer
Measured: 8 weeks
Change in uricemia concentration
Change in uricemia concentration (mg/l) from baseline to week 08. By spectrophotometer
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start20 Dec 2017
- Primary completion15 Feb 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CN NGANOU-GNINDJIO, MD, MSc, Yaounde Central Hospital
- Investigators
- Chris Nadege NGANOU-GNINDJIO, MD, MAS, Principal investigator, Yaounde Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222686
- Sponsor's protocol ID
- CARE-PLP
- Acronym
- CARE-PLP
- Status last verified
- Jan 2020
- First submitted
- 8 Apr 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale and Design of a Simple Randomized Trial Evaluating Losartan and Perindopril in Blacks Type 2 Diabetics Patients: the Cardiac and Renal Protection With Losartan or Perindopril (CARE-PLP) Trial
- ClinicalTrials.gov ID
- NCT04222686
- Acronym / sponsor ID
- CARE-PLP / CARE-PLP
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Angiotensin Converting Enzymes Inhibitor, Angiotensin II Receptor Blockers, Type 2 Diabetes, Exercise induced urinary albumin excretion, Blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 10 Jan 2020 (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.
The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.
Detailed description
Given the particularity of the renin-angiotensin system in black subjects, the CARE-PLP study fulfills this objective with the comparison of Losartan and Perindopril after 08 weeks of administration in a subsaharan African population.
Aim: The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients
Methods: CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.
Progress: Recruitment for CARE-PLP was completed in february 2018 with 29 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon
| Arm | Type | Receives |
|---|---|---|
| Perindopril Arm | Active comparator | Drug: Perindopril Arginine10 mg Perindopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks. |
| Losartan Arm | Active comparator | Drug: Losartan Potassium100 mg Losartan tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 Diabetics subjects
- Urinary albumin excretion >30 g/day or Blood pressure > 140/90
- On a stable antidiabetic and antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. The pharmacological treatment should not include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker
- Subject must not present any contraindication to exercise
- Before any study-specific procedure, the appropriate written informed consent must be obtained.
Key exclusion criteria (4 listed)
- Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
- Signs of exercise intolerance
- Out of sight.
- Withdrawal of consent
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 ArginineAlso: Perindopril10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks. | Drug | Perindopril Arm |
| Losartan PotassiumAlso: Losartan100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks. | Drug | Losartan Arm |
Primary outcome
Variation of exercise-induced urinary albumin excretion
Time frame: 8 weeks
Variation of exercise-induced urinary albumin excretion (mg/j) between week 0 and week 8. By nephelometry method.
6 secondary outcomes
Change in rest urinary albumin excretion
Time frame: 8 weeks
Change in mitral E/Ea ratio
Time frame: 8 weeks
Change in nycthemeral blood pressure profile (mmHg)
Time frame: 8 weeks
Change in concentration of antioxidants markers (micromol)
Time frame: 8 weeks
Change in lipid profile (triglycerides, Total cholesterol, HDL-cholesterol, LDL-cholesterol) on g/l
Time frame: 8 weeks
Change in uricemia concentration
Time frame: 8 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 10 Jan 2020.
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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.
Chris Nadege NGANOU-GNINDJIO, MD, MAS 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 Arginine and Losartan Potassium in people with Type 2 Diabetes Mellitus, 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 5 inclusion and 4 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 10 Jan 2020. 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?
Variation of exercise-induced urinary albumin excretion (time frame: 8 weeks). 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 10 Jan 2020.