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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00157508 |
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Date of registration:
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08/09/2005 |
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Primary sponsor: |
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Public title:
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Renal and Systemic Effects of NCX4016 in Patients With Type 2 Diabetes and Early Nephropathy
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Scientific title:
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A Pilot, Randomised, Double-Blind, Cross-Over Study to Assess the Renal and Systemic Effects of NCX4016 in Patients With Type 2 Diabetes and Early Nephropathy |
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Date of first enrolment:
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March 2003 |
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Target sample size:
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13 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00157508 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Countries of recruitment
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Italy
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Contacts
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Name:
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Piero Ruggenenti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mario Negri Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female patients affected by type 2 diabetes with stable metabolic control
(HbA1c < 9%), and stable systemic blood pressure control (SBP/ DBP < 160/90 mmHg).
- Presence of early nephropathy (overnight albumin excretion rate > 20 ?g/ min for at
least 6 months), without overt renal insufficiency (serum creatinine concentration <
2 mg/dl).
- Age between 18 and 75 years.
- Written signed informed consent; patient willing and able to comply with all study
procedures and scheduled visits.
Exclusion Criteria:
- History of any form of allergic reactions or hypersensitivity or intolerance or
contraindication to acetylsalicylic acid or nitrates.
- Patients under the age of 18 or above 75.
- Patients who are not able to give an informed consent or inadequate comprehension of
study risks and requirements.
- Patients who are unable to comply with the requirements of the study protocol.
- Chronic alcohol or drug abuse (current or within the past year).
- Pregnancy and lactation.
- If women of child-bearing potential, a pregnancy test must be performed before
inclusion and after the study, and reliable contraceptive methods followed.
- Evidence for non-diabetic renal disease.
- Patients with duodenal/gastric ulcer history, or gastrointestinal bleeding over the
last 6 months.
- Patients with liver insufficiency (ASAT, ALAT > 2 times the upper normal limit).
- Patients with platelet counts < 100,000 cells/mm3.
- Patients with hemorrhagic diathesis.
- Patients on antiinflammatory or immunosuppressive therapy over the last 6 months.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Early Nephropathy
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Type 2 Diabetes
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Intervention(s)
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Drug: nitroaspirin
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Primary Outcome(s)
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Albuminuria after 4 weeks of treatment
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Cardiac and renal hemodynamics after 4 weeks of treatment
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Insulin sensitivity after 4 weeks of treatment
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Secondary ID(s)
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NCX4016-X-204
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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