CClinicalTrials.gg
Status unknownNCT01230034Updated Oct 28, 2010

Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic and Hypertensive Patients With Microalbuminuria

A Phase 3 interventional study of Ramipril and Imidapril in Hypertension, Type 2 Diabetes Mellitus and Microalbuminuria, sponsored by University of Pavia. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-10-28.

Sponsored by University of Pavia · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension
  • Type 2 Diabetes Mellitus
  • Microalbuminuria

Keywords

  • Imidapril, Ramipril, Hypertension, Type 2 diabetes mellitus, Microalbuminuria
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 206 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Pavia is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
206 participants (estimated)

Study arms

  • Experimental
    Imidapril

    10 and 20 mg/day, pill

    Drug: Imidapril

  • Active comparator
    Ramipril

    5 and 10 mg/day, pill

    Drug: Ramipril

Interventions

  • DrugRamipril

    pill, 5 and 10 mg/day, od, 24 weeks

  • DrugImidapril

    pill, 10 and 20 mg/day, od, 24 weeks

06

What researchers measure

Primary outcomes

  1. Size of the reduction of urinary albumin in 24 hours to the various controls

    Time frame: 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.

    Time frame: After 12 weeks from the beginning

07

Study locations

1 of 1 sites recruiting
  • University of Pavia
    Pavia, 27100, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01230034
Lead sponsor
University of Pavia
First posted
Oct 28, 2010
Start date
Oct 2010
Primary completion
Jun 2011 (estimated)
Completion
Jul 2011 (estimated)
Last update
Oct 28, 2010

Study contacts

Roberto Fogari, MD
Contact
r.fogari@unipv.it
+39 0382 526217
Giuseppe Derosa, MD
Contact
giuseppe.derosa@unipv.it
+39 0382 502614
Roberto Fogari, MD
study director · University of Pavia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion