HypertensionPhase 3NCT01230034
Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic and Hypertensive Patients With Microalbuminuria
A Phase 3 study testing Ramipril and Imidapril in people with Hypertension and Type 2 Diabetes Mellitus, run by University of Pavia at 1 site in Italy.
Trial summary
Numerous clinical and experimental data show that the elective treatment of diabetic nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS). Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients with concomitant non-diabetic nephropathy, on the other… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes Mellitus, Microalbuminuria
- What is being tested?
- Ramipril and Imidapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Jul 2011
- Phase
- Phase 3
- 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
- Blood pressure> 130/80 ≤ 170/100 mmHg at the end of the period of wash-out
- Type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%)
- Microalbuminuria in the upper range of normal (> 150 <300 mg/24 h)
Who cannot join
- Pregnancy, lactation or women of childbearing age.
- Inability to stop treatment in place for a few days during the wash-out.
- Sitting diastolic blood pressure> 100 mmHg or systolic pressure> 170 at the end of the wash-out.
- History of hypertensive encephalopathy or cerebrovascular accident within 12 months prior.
- Secondary hypertension.
- Heart failure
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- Acute myocardial infarction; angina pectoris
- Liver and kidney dysfunction
- Known hypersensitivity to ACE inhibitors
- All other physiological or pathological condition that the physician may affect the evaluation of the parameters under study or interfere with the proper conduct of the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Pavia
Pavia, 27100
Giuseppe Derosa, MD, +39 0382 526217, giuseppe.derosa@unipv.it
Giuseppe Derosa, MD
About this study
Official title: Randomized, Controlled, PROBE Trial, Evaluating the Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic Patients and Mild to Moderate Hypertension With Microalbuminuria
Numerous clinical and experimental data show that the elective treatment of diabetic nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS). Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients with concomitant non-diabetic nephropathy, on the other hand, drugs blocking the renin-angiotensin system available so far, namely ACE inhibitors and angiotensin antagonists II have proven effective in reducing proteinuria in power even if different therapeutic drug to drug. ACE inhibitors are one of the most known and used treatment options for blocking the renin-angiotensin system in patients with microalbuminuria. Drugs such as enalapril, lisinopril and ramipril are standard therapy in diabetic patients with micro or macroalbuminuria. However, it is still unclear whether their efficacy is, from this point of view, the same or varies from drug to drug. This is particularly true in the diabetic microalbuminuria, a condition in which there is sufficient documentation to prove that ramipril is effective. The main objective of this study was to assess the magnitude and trend of the time and to the antiproteinuric effect of antihypertensive 10-20mg/die imidapril versus ramipril 5-10 mg / day in hypertensive patients with type 2 diabetes and microalbuminuria.
- Conditions
- Hypertension, Type 2 Diabetes Mellitus, Microalbuminuria
- Being tested
- Ramipril, Imidapril
- Keywords
- Imidapril, Ramipril, Hypertension, Type 2 diabetes mellitus, Microalbuminuria
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
pill, 5 and 10 mg/day, od, 24 weeks
ImidaprilDrug
pill, 10 and 20 mg/day, od, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Imidapril | Experimental | 10 and 20 mg/day, pill Receives: Drug: Imidapril |
| Ramipril | Active comparator | 5 and 10 mg/day, pill Receives: Drug: Ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of the reduction of urinary albumin in 24 hours to the various controls
Measured: After 12 weeks from the beginning
Secondary outcomes (1)
1. Size of the reduction of mean 24-hour average daytime and nighttime average. 2. Size of the reduction of central blood pressure. 3. Magnitude of changes in plasma concentrations of angiotensin II, bradykinin and BNP after 24 weeks of treatment.
Measured: After 12 weeks from the beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Investigators
- Roberto Fogari, MD, Study director, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230034
- Sponsor's protocol ID
- UNIPV001DIM2010
- Other IDs
- 2010-023332-17
- Status last verified
- Oct 2010
- First submitted
- 27 Oct 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, PROBE Trial, Evaluating the Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic Patients and Mild to Moderate Hypertension With Microalbuminuria
- ClinicalTrials.gov ID
- NCT01230034
- Acronym / sponsor ID
- UNIPV001DIM2010
- Conditions
- Hypertension, Type 2 Diabetes Mellitus, Microalbuminuria
- Keywords
- Imidapril, Ramipril, Hypertension, Type 2 diabetes mellitus, Microalbuminuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 28 Oct 2010 (estimated)
- 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.
Numerous clinical and experimental data show that the elective treatment of diabetic nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS). Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients with concomitant non-diabetic nephropathy, on the other hand, drugs blocking the renin-angiotensin system available so far, namely ACE inhibitors and angiotensin antagonists II have proven effective in reducing proteinuria in power even if different therapeutic drug to drug. ACE inhibitors are one of the most known and used treatment options for blocking the renin-angiotensin system in patients with microalbuminuria. Drugs such as enalapril, lisinopril and ramipril are standard therapy in diabetic patients with micro or macroalbuminuria. However, it is still unclear whether their efficacy is, from this point of view, the same or varies from drug to drug. This is particularly true in the diabetic microalbuminuria, a condition in which there is sufficient documentation to prove that ramipril is effective. The main objective of this study was to assess the magnitude and trend of the time and to the antiproteinuric effect of antihypertensive 10-20mg/die imidapril versus ramipril 5-10 mg / day in hypertensive patients with type 2 diabetes and microalbuminuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imidapril | Experimental | Drug: Imidapril10 and 20 mg/day, pill |
| Ramipril | Active comparator | Drug: Ramipril5 and 10 mg/day, pill |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Blood pressure> 130/80 ≤ 170/100 mmHg at the end of the period of wash-out
- Type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%)
- Microalbuminuria in the upper range of normal (> 150 <300 mg/24 h)
Key exclusion criteria (10 listed)
- Pregnancy, lactation or women of childbearing age.
- Inability to stop treatment in place for a few days during the wash-out.
- Sitting diastolic blood pressure> 100 mmHg or systolic pressure> 170 at the end of the wash-out.
- History of hypertensive encephalopathy or cerebrovascular accident within 12 months prior.
- Secondary hypertension.
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 |
|---|---|---|
| Ramiprilpill, 5 and 10 mg/day, od, 24 weeks | Drug | Ramipril |
| Imidaprilpill, 10 and 20 mg/day, od, 24 weeks | Drug | Imidapril |
Primary outcome
Size of the reduction of urinary albumin in 24 hours to the various controls
Time frame: After 12 weeks from the beginning
1 secondary outcome
1. Size of the reduction of mean 24-hour average daytime and nighttime average. 2. Size of the reduction of central blood pressure. 3. Magnitude of changes in plasma concentrations of angiotensin II, bradykinin and BNP after 24 weeks of treatment.
Time frame: After 12 weeks from the beginning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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.
Roberto Fogari, MD study director
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramipril and Imidapril in people with Hypertension and Type 2 Diabetes Mellitus, run by University of Pavia at 1 site in Italy.
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 10 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: status not confirmed, as of the sponsor's last update on 28 Oct 2010. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Fogari, MD (+39 0382 526217, r.fogari@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of the reduction of urinary albumin in 24 hours to the various controls (time frame: After 12 weeks from the beginning). 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 28 Oct 2010.