An open label prospective pilot-study to determine the improvement of impaired endothelial function and endothelial progenitor cell numbers following treatment with Aliskiren 300 mg in patients with coronary artery disease and hypertensio

• Conditions: Determination of the improvement of impaired endothelial function and endothelial progenitor cell numbers following treatment with Aliskiren 300 mg in patients with coronary artery disease and hypertension.; MedDRA version: 14.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-015600-26-DE
• Lead Sponsor: niversitätsklinikum Würzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-09
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

•Hypertension (systolic RR >140 mmHg)
•Established coronary artery disease (based on invasive coronary angiography)
•Ensured compliance: patient should be able to cooperate with protocol regimen and follow-up
•female patients must be post-menopausal. Post-menopausal and not of child-bearing potential females are defined as females who have had:
o= 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or
o= 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or
osurgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

•Age below 18 years and over 85 years.
•Pregnancy or breast-feeding
•Unstable Angina pectoris or within 3 months after myocardial infarction
•Coronary stent implantation within the last 3 months
•Heart failure NYHA III and IV
•Patients who cannot come to revisits
•Current infections
•Patients with life expectancy below 12 months
•Alcohol or drug abuse within the last 5 years
•Creatinine > 2.5 mg/dl
•GFR= 30 (ml/min) / 1.73 m²
•Hyperkalemia > 5 mmol/l
•Actual or anamnestic cerebrovascular events
•Hypotension
•Angio-oedema related to inhibitors of the renin-angiotensin-system in the medical history
•Hypersensitivity to the active substance
•Simultaneous administration of Aliskiren and Ciclosporin ( a high efficient P-gp-Inhibitor) and other efficient P-gp-Inhibitors (Chinidin, Verapamil)
•Combination therapy with ACE inhibitor and ARBs
•Therapy with aldosterone antagonists
•No stable dose of statins, beta blockers and ACE inhibitors or ARB for 4 weeks prior to Visit 1.
•Any medication with major impact on endothelial function such as carvediolol, nebivolol, monoxidin, long lasting nitrate preparations, alcohol, caffeine, PDE5 inhibitors not discontinued for at least 24 hours before measurements.
•Participation in another clinical trial within 30 days before study start or during the trial.
•Participation of patient who might be dependent on the investigator, also the spouce, parents or children.

Study & Design

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