| Trial ID: | L4805 |
| Source ID: | NCT01393808
|
| Associated Drug: |
Paricalcitol
|
| Title: |
Salt Intake and Antiproteinuric Effect of Paricalcitol in Type 2 Diabetes
|
| Acronym: |
PROCEED
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Paricalcitol|OTHER: placebo
|
| Outcome Measures: |
Primary: Changes in urinary albumin excretion from baseline at 4 month., At baseline and 1,2,3 and 4 month. | Secondary: Ambulatory and 24-hour blood pressure profile., At 1 month.|Ambulatory and 24-hour blood pressure profile., At 2 month.|Ambulatory and 24-hour blood pressure profile., At 3 month.|Ambulatory and 24-hour blood pressure profile., At 4 month.
|
| Sponsor/Collaborators: |
Sponsor: Mario Negri Institute for Pharmacological Research | Collaborators: Abbott
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
112
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-09
|
| Completion Date: |
2015-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-03
|
| Locations: |
ASL of Ponte San Pietro - Diabetologic Unit, Brembate, Bergamo, 24030, Italy|Clinical Research Center fo Rare Diseases Aldo and Cele Daccò, Ranica, Bergamo, 24020, Italy|Azienda Ospedaliera di Treviglio e Caravaggio - Unit of Diabetology and Metabolic Diseases, Romano di Lombardia, BG, Italy|Azienda Ospedaliera Bolognini - Unità di Medicina, Seriate, BG, Italy|Azienda Ospedaliera di Treviglio e Caravaggio - Unit of Diabetology and Metabolic Diseases, Treviglio, BG, Italy|Azienda Ospedaliera Ospedali Riuniti di Bergamo, Bergamo, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT01393808
|
