Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Patients With Type 2 Diabetes and Incipient or Overt Nephropathy
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2 diabetes patients with incipient or overt nephropathy
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Male and/or female patients from 30-80 years of age.
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Type 2 diabetes (defined using World Health Organization criteria)
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Incipient or overt nephropathy (urinary albumin excretion 100 but ≤ 2000 mg/day).
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Glomerular filtration rate (GFR) 40ml per minute
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To be eligible for randomization, patients must fulfill the following criteria:
- Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at Visit 3 (Day -1, Period 1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to Visit 2 (Run-in period)
- Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at Visit 3 (Day -1, Period 1)
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Female patients must be postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening
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Oral body temperature within the range 35.0-37.5 °C
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Able to provide written informed consent prior to study participation.
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Able to communicate well with the investigator and comply with the requirements of the study.
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Patients must be willing and medically able to discontinue anti-hypertensive treatment or any other medication which is prohibited in the study protocol.
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Patients must be on stable hypoglycemic medications for at least 8 weeks prior to visit 1 (Screening visit).
Exclusion criteria
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Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
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Severe Hypertension Grade 3 WHO classification Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg)
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Acetylsalicyclic acid (ASA) treatment >1g/day or regular use of Non steroidal anti-inflammatory drugs (NSAIDs)
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Kidney disease not caused by diabetes or hypertension
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Serum potassium < 3.5 or > 5.1 mEq/L
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GFR < 40 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula
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Serum albumin < 2.0mg/dL
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History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit 1
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Transient ischemic cerebral attack during the 6 months prior to Visit 1
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Current diagnosis of heart failure New York Heart Association (NYHA) Class II-IV
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History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
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Second or third degree heart block without a pacemaker
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Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
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Clinically significant valvular heart disease
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Type 1 diabetes mellitus
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Uncontrolled Type II diabetes mellitus Hemoglobin subtype A1C (HbA1C) >11 %
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History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
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Pregnant or nursing women
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Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
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Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
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Significant illness within the two weeks prior to dosing.
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Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1
- Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
- Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
- Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- Current treatment with cholestyramine or cholestipol resins
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History of immunocompromise, including a positive HIV test result.
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History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
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History of drug or alcohol abuse within the 12 months prior to dosing.
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Persons directly involved in the execution of this protocol.
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Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety
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History of noncompliance to medical regimens or unwillingness to comply with the study protocol
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Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors and/or to thiazide diuretics or other sulfonamide derived drug
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Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
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Patients who previously participated in any Aliskiren study.
Other protocol-defined inclusion/exclusion criteria may apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
26 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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