patients with hypertension, Type 2 DM and proteinuria
Conditions
Sponsors
Novartis Ireland Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in this study are: • Outpatients 18 years of age to 75. • Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. • Patients with hypertension (currently treated with antihypertensive medication(s) or MSSBP > 140 mmHg or MSDBP > 90 mmHg) at Visit 1. • Urine dipstick for protein = trace at Visit 1. • Proteinuria as defined by a spot urine specimen collection at Visit 1 (UACR = 300mg/g and = 3500 mg/g). • Proteinuria demonstrated in 2 of 3 early morning void spot urine specimen collections at Visit 5 or Optional Visit 501 (UACR = 100 mg/g and = 3500 mg/g.). • MSSBP =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who previously participated in any aliskiren study. • Severe hypertension (grade 3 WHO classification; MSSBP ? 180 mmHg and/or MSDBP ? 110 mmHg). • Kidney disease not caused by diabetes or hypertension. • History of chronic urinary tract infections (UTI) • Serum potassium 5.1 mEq/L. • GFR 11 %) • 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 as determined by any one of the following: SGOT or SGPT values exceeding 2 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt. • Current obstruction of the urinary tract or difficulty in voiding due to mechanical or inflammatory conditions which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator. • History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. • History or evidence of drug or alcohol abuse within the last 12 months. • Pregnant or nursing women. • 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. • Known or suspected contraindications to the study medications, including history or allergy to angiotensin receptor blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to: • Demonstrate the efficacy of aliskiren on proteinuria when added to standardized losartan therapy (100mg OD) and optimal antihypertensive therapy in patients with hypertension and Type 2 DM by testing the hypothesis of superior reduction in proteinuria (% reduction in UACR) from baseline to study end when compared to placebo. ;Secondary Objective: The secondary objectives of this study are to: • Evaluate the proportion of patients who have their UACR reduced by = 50% from baseline to study end. • Evaluate the effect of aliskiren on UAER from baseline to study end. • Evaluate the effect of aliskiren on MSSBP and MSDBP in this patient population. • Evaluate the effect of aliskiren 150 mg OD versus forced titration to aliskiren 300 mg OD on urinary albumin/creatinine ratio reductions by comparing month 3 to month 6. • Evaluate the safety and tolerability of aliskiren in this patient population. • Explore the impact of treatment on biomarkers as compared to baseline. • Explore the effects of aliskiren on GFR. • Explore the effect of aliskiren on QoL as assessed by the Psychological General Well-Being Index (PGWBI) ;Primary end point(s): The primary efficacy variable is % change from baseline in urinary albumin/creatinine ratio (mg/g), calculated as 100*(post value – baseline)/baseline (%). | — |
Countries
Denmark, Ireland, Italy, Slovakia, Spain, United Kingdom
Outcome results
None listed