A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus - NCT00660309-02115 (Clinical Trial 215812)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy215812.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Boston |
|
State:
|
|
MA |
| Zip Code: |
|
02115 |
| Conditions: |
|
Type 2 Diabetes Mellitus |
| Purpose: |
|
The study objective is to compare the effects of single and multiple doses of the oral
direct renin inhibitor aliskiren and the angiotensin receptor antagonist irbesartan on renal
blood flow, glomerular filtration rate, and retinal blood flow in patients with type 2
diabetes mellitus.
|
| Study summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Patients must have been diagnosed with type 2 diabetes mellitus at least 6 months
before the study, with history of hypertension or newly diagnosed hypertension.
- Patients must be on a stable dose of hypoglycemic medications for at least 8 weeks
prior to the study.
- Patients must be medically able to discontinue anti- hypertensive medications for the
duration of the study.
- Female patients must be postmenopausal or surgically sterilized
Exclusion Criteria:
- Patients with Type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus.
- Patients with glaucoma, or prior ocular surgery.
- Patients with renal disease not caused by diabetes or hypertension.
- Patients with heart failure or high serum potassium.
- Patients with history of clinically significant drug or atopic allergy, acute or
chronic respiratory disease, history of malignancy, or history of myocardial
infarction, unstable angina pectoris, coronary bypass surgery, or any coronary
intervention (PCI) during the 6 months prior to the study.
- Any surgical or medical condition which may jeopardize the patient in case of
participation in the study.
- Participation in any clinical investigation within 4 weeks prior to the study.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to the study
Other protocol-defined inclusion/exclusion criteria may apply. |
|
|
|
| Study is available at: |
|
Novartis Investigator Site
Boston, MA 02115
United States
Primary Contact:
Novartis
Phone: 862-778-8300
Secondary Contact:
Novartis
Phone: 862-778-8300 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|