| Outcome Measures: |
Primary: Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment., 9 weeks | Secondary: Change from baseline of glomerular filtration rate (GFR) in response to L-NMMA infusion at the end of treatment, 9 weeks|Change from baseline of filtration fraction (FF) in response to L-NMMA infusion at the end of treatment., 9 weeks|Change from baseline of renal vascular resistance (RVR) in response to L-NMMA infusion at the end of treatment., 9 weeks|Change from baseline of RPF in response to L-arginine infusion at the end of treatment., 9 weeks|Change from baseline of GFR in response to L-arginine infusion at the end of treatment, 9 weeks|Change from baseline of FF in response to L-arginine infusion at the end of treatment., 9 weeks|Change from baseline of RVR in response to L-arginine infusion at the end of treatment., 9 weeks|Change from baseline of mean arterial pressure (MAP) and pulse rate (PR) in response to L-NMMA infusion at the end of treatment., 9 weeks|Change from baseline of MAP and PR in response to L-arginine infusion at the end of treatment., 9 weeks|Change from baseline of the laboratory parameters angiotensin II (ANG II), aldosterone, asymmetrical dimethylarginine (ADMA), L-arginine, urinary nitrate/nitrite (UNOx), and urinary albumin excretion at the end of treatment, 9 weeks|Change from baseline of the pre-L-NMMA RPF at the end of treatment, 9 weeks|Change from baseline of the pre-L-NMMA GFR at the end of treatment, 9 weeks|Change from baseline of the pre-L-NMMA FF at the end of treatment., 9 weeks|Change from baseline of the pre-L-NMMA RVR at the end of treatment., 9 weeks|Change from baseline of the urinary excretion parameters creatinine, sodium, potassium, and urea at the end of treatment., 9 weeks|Blood pressure response and control at the end of treatment, 9 weeks|Change from baseline of central blood pressure and augmentation index (by pulse wave analysis) at the end of treatment., 9 weeks|Change from baseline of RPF in response to Vitamin C infusion at the end of treatment, 9 weeks|Change from baseline of GFR in response to Vitamin C infusion at the end of treatment, 9 weeks|Change from baseline of FF in response to Vitamin C infusion at the end of treatment., 9 weeks|Change from baseline of RVR in response to Vitamin C infusion at the end of treatment., 9 weeks|Change from baseline of MAP and PR in response to Vitamin C infusion at the end of treatment., 9 weeks|Incidence of adverse events, week -2 and 9 weeks|Changes from base line in routine laboratory data at the end of the study, 9 weeks|Changes in vital signs, 9 weeks|Changes from screening in physical examination at the end of the study, - 4 weeks and 9 weeks|Changes from screening in ECG at the end of the study, - 4 weeks and 9 weeks
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| Locations: |
Boehringer Ingelheim Investigational Site, Lyon, France|Boehringer Ingelheim Investigational Site, Montpellier, France|Friedrich-Alexander-Universität, Erlangen, 91054, Germany|Boehringer Ingelheim Investigational Site, Nürnberg, 90402, Germany|Universität Erlangen-Nürnberg, Nürnberg, 90471, Germany|Edificio de Medicina Comunitaria, Madrid, 28041, Spain
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