Linagliptin in Patients with Hypertension and Albuminuria MedDRA version: 16.1 Level: PT Classification code 10038464 Term: Renal hypertension System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 16.1 Level: PT Classification code 10001580 Term: Albuminuria System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Trajenta
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Trajenta
CAS Number: 668270-12-0
Other descriptive name: LINAGLIPTIN
Concentration unit: mg milligram(s)
Concentration
Sponsors
Profil Mainz GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient has signed and dated written informed consent to participate in the trial 2.Arterial hypertension 3.Stable antihypertensive treatment within the last 3 months 4.Age = 45 – = 80 years 5.Micro- or macroalbuminuria defined as UACR in morning urine > 20 mg/g in female and > 30 mg/g in male and/or arterial hypertension for more than 5 years currently treated with two or more antihypertensive drugs to control blood pressure and a history of cardiovascular disease or stroke. 6.Patient consents that his/her family physician will be informed of trial participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: 1.History of type 1 diabetes 2.History of type 2 diabetes 3.Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg) 4.Acute infections 5.Any history of glomerulonephritis 6.Any kidney disease not caused by hypertension as judged by the Investigator 7.Glomerular filtration rate (GFR) 5.5 mmol/L 15.Pregnancy or breast feeding 16.Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. 17.Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 3 months 18.Any elective surgery during study participation 19.Uncontrolled unstable angina pectoris 20.Intake of Coumarin or coumarin derived compounds such as phenprocoumon (Marcumar) or warfarin (Coumadin, Warfant) 21.Intake of rifampicin or carbamazepine 22.HbA1c = 6,5% 23.A Body Mass Index of > 35 kg/m² 24.CHF NYHA stage III – IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the effect of Linagliptin in comparison to placebo on the urine albumin-to-creatinine ratio (UACR) in patients with high blood pressure and an increased albumin excretion. ;Secondary Objective: NA;Primary end point(s): •Albumin/Creatinine Ratio (UACR) in 24h hour urine under standardized in house condition •24 hour urinary sodium excretion under standardized in house condition •Fasting cystatin C •Fasting serum and urinary neutrophil gelatinase-associated lipocalin (NGAL) •Urinary N-acetyl-ß-o-glucosaminidase •Urinary nephrin •Urinary podocin •Fasting cGMP •Fasting serum ADMA •Fasting hsCRP •Fasting TGF-ß1 •Fasting serum and urinary IL-18 •Retinal endothelial function •Retinal microvascular blood flow •24h blood pressure measurements ;Timepoint(s) of evaluation of this end point: after approx. 16 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Germany
Contacts
Public ContactContract Research Organisation
Clinlogix Europe GmbH
Outcome results
None listed