|
Main
|
|
Note: This record shows only 22 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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
31 August 2015 |
|
Main ID: |
NCT01208701 |
|
Date of registration:
|
19/09/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Effects of Atorvastatin on the Nitrogen Oxide-system in Patients With Type 2 Diabetes and Nephropathy
STAD |
|
Scientific title:
|
The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy |
|
Date of first enrolment:
|
May 2010 |
|
Target sample size:
|
25 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01208701 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Frank H Christensen, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Medical Research |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Men and women
- minimum 40 years
- Chronic Kidney disease
- Estimated GFR (eGFR) between 30 and 90 ml/min
- Diabetes Mellitus type II
Exclusion Criteria:
- Nephrotic Syndrome
- Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain
disease
- Neoplastic disease
- Alcohol abuse,
- Drug abuse
- Pregnancy or nursing
- Blood donation within a month before examination
- Hgb < 6,0
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cardiovascular Diseases
|
|
Diabetes Mellitus
|
|
Nephropathy
|
|
Intervention(s)
|
|
Drug: Unikalk
|
|
Drug: Atorvastatin
|
|
Primary Outcome(s)
|
|
Fractional excretion of sodium
[Time Frame: 5 days treatment]
|
|
Secondary Outcome(s)
|
|
Plasma renin concentration
[Time Frame: 5 days]
|
|
Augmentations index
[Time Frame: 5 days]
|
|
Arterial stiffness
[Time Frame: 5 days]
|
|
Systolic blood pressure
[Time Frame: 5 days]
|
|
Plasma angiotensin II concentration
[Time Frame: 5 days]
|
|
Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)
[Time Frame: 5 days]
|
|
Secondary ID(s)
|
|
EBP-FHC-2010-3
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|