Effects of Linagliptin on Endothelial- , Renal-, and Retinal Function in Comparison to Placebo in Patients with Arterial Hypertension and Albuminuria

• Conditions: inagliptin in Patients with Hypertension and Albuminuria; MedDRA version: 16.1Level: PTClassification code 10038464Term: Renal hypertensionSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 16.1Level: PTClassification code 10001580Term: AlbuminuriaSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-004300-35-DE
• Lead Sponsor: Profil Mainz GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-05
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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) < 30 ml/min (estimated by use of the Modification of Diet in Renal Disease (MDRD) formula)
8.Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
9.History of severe or multiple allergies
10.Treatment with any other investigational drug within 3 months before trial entry
11.Progressive fatal disease
12.History of drug or alcohol abuse in the past 2 years
13.Condition after kidney transplantation
14.Serum potassium > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>•24 hour urinary sodium excretion under standardized in house condition<br>•Fasting cystatin C<br>•Fasting serum and urinary neutrophil gelatinase-associated lipocalin (NGAL) <br>•Urinary N-acetyl-ß-o-glucosaminidase <br>•Urinary nephrin <br>•Urinary podocin <br>•Fasting cGMP<br>•Fasting serum ADMA<br>•Fasting hsCRP<br>•Fasting TGF-ß1<br>•Fasting serum and urinary IL-18 <br>•Retinal endothelial function<br>•Retinal microvascular blood flow <br>•24h blood pressure measurements<br>;Timepoint(s) of evaluation of this end point: after approx. 16 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA