Status:
COMPLETED
A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Novartis
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study objective was to assess the effect of single and multiple doses of aliskiren on renal plasma flow, glomerular filtration rate and to compare the effects of single and multiple doses of alisk...
Eligibility Criteria
Inclusion
- Hypertensive, male and females of non-child bearing potential patients, with type 2 diabetes mellitus (T2DM) (diagnosed at least 8 weeks before Screening), with or without renal impairment; estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m\^2, documented at least 3 months before the study start, aged 18-75 years with a minimum body weight of 50 kg and having an appropriate intravenous access as determined by the study staff, able to communicate well were enrolled in the study.
- 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.
Exclusion
- Patients with type 1 diabetes mellitus or uncontrolled T2DM (HbA1C\> 11%), eGFR \<40 mL/min/1.73 m\^2 (calculated by the Modification of Diet in Renal Disease (MDRD) formula), renal disease not caused by diabetes or hypertension, serum potassium \< 3.5 or \> 5.1 mEq/L, heart failure (New York Heart Association (NYHA) Class II-IV) or history of acute/decompensated heart failure within the 6 months prior to dosing, history of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to the baseline visit, history of malignancy including leukemia and lymphoma within past five years, hypertensive encephalopathy any time in the past or cerebrovascular accident within the 6 months prior to the baseline visit, or with history of drug or alcohol abuse within the 12 months prior to dosing were excluded from the study.
- Patients with glaucoma, or prior ocular surgery.
- Patients with renal disease not caused by diabetes or hypertension.
- 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 (percutaneous coronary intervention; PCI) during the 6 months prior to the study.
- Patients who had used any prescription drugs which may affect the renin-angiotensin-aldosterone system or with known effect on renal hemodynamics within 2 weeks prior to dosing and during the study, over-the-counter (OTC) medication within two (2) weeks prior to dosing,
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00660309
Start Date
April 1 2008
End Date
December 1 2009
Last Update
August 29 2012
Active Locations (1)
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1
Novartis Investigator Site
Boston, Massachusetts, United States, 02115