INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria (NCT01398423) | Clinical Trial Compass
CompletedPhase 2
INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria
United States88 participantsStarted 2011-06
Plain-language summary
A randomized, double-blind, active control trial to determine the safety, efficacy and pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.
Who can participate
Age range18 Years ā 85 Years
SexALL
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Inclusion criteria
ā. Men or women, 18 to 85 years of age, inclusive.
ā. Able and willing to understand and provide written informed consent.
ā. Documented hypertension defined by 1 of the following:
ā. Documented type 2 diabetes mellitus defined by 1 of the following:
ā. Documented nephropathy evidenced by a UACR of 300 to 3000 mg/g.
ā. Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age \>40 years without menses for ā„2 years) must agree to use 1 of the following forms of reliable contraception:
Exclusion criteria
ā. Required use of an ACE inhibitor, ARB, direct renin inhibitor, or aldosterone antagonist other than study drug, while on the study.
ā. Systolic blood pressure \>180 mm Hg (mean of 3 seated readings, 5 minutes apart, using the subject's dominant arm).
ā. Chronic kidney disease stage 4 or higher defined as an estimated glomerular filtration rate \<30 mL/min per 1.73 m2 (abbreviated MDRD equation).
ā. Hepatic impairment defined by serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>2 x the upper limit of normal.
ā. Diagnosis of type 1 diabetes or non-diabetic renal disease, including but not limited to renal-artery stenosis, primary glomerular disease, autoimmune renal diseases, etc.
ā. Severe anemia defined as hemoglobin \< 8 g/dL.
ā. Congestive heart failure with New York Heart Association Class II, III, or IV symptoms.
ā. Thiamine (Vitamin B1) deficiency or known alcohol abuse within the past year. If alcohol abuse is suspected, subject must have a normal thiamine blood level documented prior to study entry.