Trial reportBritish journal of clinical pharmacology2006
Aliskiren, a novel orally effective renin inhibitor, exhibits similar pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects.
Trial report in British journal of clinical pharmacology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed.
- A Randomized, Single-Center, Double-Blind, Placebo-Controlled Multiple-Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Imarikiren in Healthy Adult Nonelderly and Elderly Male Subjects.Journal of clinical pharmacology · 2018Trial
- Pharmacokinetics of aliskiren in patients with end-stage renal disease undergoing haemodialysis.Clinical pharmacokinetics · 2012Trial
- Rifampicin reduces the plasma concentrations and the renin-inhibiting effect of aliskiren.European journal of clinical pharmacology · 2010Trial
- Pharmacokinetics, safety and tolerability of single and multiple oral doses of aliskiren in healthy Chinese subjects: a randomized, single-blind, parallel-group, placebo-controlled study.Clinical drug investigation · 2010Trial
- The Advent of Cuffless Mobile Device Blood Pressure Measurement: Remaining Challenges and Pitfalls.Korean circulation journal · 2022Review
- The role of direct renin inhibitors in the treatment of the hypertensive diabetic patient.Therapeutic advances in endocrinology and metabolism · 2013Article
- Oral renin inhibitors in clinical practice: a perspective review.Therapeutic advances in chronic disease · 2012Article
- Aliskiren, amlodipine and hydrochlorothiazide triple combination for hypertension.Expert review of cardiovascular therapy · 2012Review
- Renin and cardiovascular disease: Worn-out path, or new direction.World journal of cardiology · 2011Article
- Role of aliskiren in blood pressure control and renoprotection.International journal of nephrology and renovascular disease · 2011Article
- Aliskiren: a review of its use as monotherapy and as combination therapy in the management of hypertension.Drugs · 2010Review
- Blocking the RAAS at different levels: an update on the use of the direct renin inhibitors alone and in combination.Vascular health and risk management · 2010Review
- Cardiovascular risk in hypertension - can we ask for more? : focus on aliskiren.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2008Article
- Now that we have a direct renin inhibitor, what should we do with it?Current hypertension reports · 2008Review
- Effects of aliskiren, a renin inhibitor, on biomarkers of platelet activity, coagulation and fibrinolysis in subjects with multiple risk factors for vascular disease.Journal of human hypertension · 2008Article
- Clinical pharmacokinetics and pharmacodynamics of aliskiren.Clinical pharmacokinetics · 2008Review
- Review
- Aliskiren--an orally active renin inhibitor. Review of pharmacology, pharmacodynamics, kinetics, and clinical potential in the treatment of hypertension.Vascular health and risk management · 2007Review
- Aliskiren exhibits similar pharmacokinetics in healthy volunteers and patients with type 2 diabetes mellitus.Clinical pharmacokinetics · 2006Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsAliskiren is the first in a new class of orally effective renin inhibitors for the treatment of hypertension. This study compared the pharmacokinetic and pharmacodynamic properties of aliskiren in Japanese and Caucasian subjects.
methodsIn this open-label, single-centre, parallel-group, single- and multiple-dose study, 19 Japanese and 19 Caucasian healthy young male subjects received a single 300-mg oral dose of aliskiren on day 1 and then aliskiren 300 mg once daily on days 4-10. Blood samples were collected for the measurement of plasma aliskiren concentration, plasma renin concentration (PRC) and plasma renin activity (PRA).
resultsPharmacokinetic parameters were comparable in Japanese and Caucasian subjects following administration of a single dose of aliskiren {ratio of geometric means: C(max) 1.12 [90% confidence interval (CI) 0.88, 1.43]; AUC(0-72 h) 1.19 [90% CI 1.02, 1.39]} and at steady state [mean ratio: C(max) 1.30 (90% CI 1.00, 1.70); AUC(0-tau) 1.16 (90% CI 0.95, 1.41)]. There was no notable difference in the plasma half-life of aliskiren between Japanese and Caucasian groups (29.7 +/- 10.2 h and 32.0 +/- 6.6 h, respectively). At steady state, peak PRC level and AUC for the concentration-time plot were not significantly different between Japanese and Caucasian subjects (P = 0.64 and P = 0.80, respectively). A single oral dose of aliskiren significantly reduced PRA to a similar extent in Japanese and Caucasian subjects (by 87.5% and 85.7%, respectively, compared with baseline; P < 0.01). Aliskiren was well tolerated by both ethnic groups.
conclusionsThe oral renin inhibitor aliskiren demonstrated similar pharmacokinetic and pharmacodynamic properties in Japanese and Caucasian subjects.
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