Women or men >35 and < 80 years of age with documented, clinically stable coronary artery disease with stable angina pectoris from the heart catheter register, II. Med. Klinik, Johannes Gutenberg-University Mainz. MedDRA version: 9.1 Level: LLT Classification code 10049194 Term: Stable angina pectoris MedDRA version: 9.1 Level: LLT Classification code 10011093 Term: Coronary atherosclerosis
Conditions
Interventions
Trade Name: Pentalong
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Johannes Gutenberg-Universität Mainz, II. Med. Klinik (ausführende Stelle), Prof. Dr. T. Münzel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be considered for admission to the trial: - Men or women > 35 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following criteria will not be included in the trial: - Clinical signs of congestive heart failure or left ventricular ejection fraction 180/110mmHg) or hypotension (systolic blood pressure 2.0 mg/dl, women: : > 1.8 mg/dl)) - Known hepatic disease or elevation of serum transaminases or gGT > 3x ULN (upper limit of normal range) - WBC >16.000 or platelet count >500.000/µl or <75.000/µl - Clinically overt hyperthyreodism - Pregnancy and lactation - Known intolerance to organic nitrates - History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharma-ceutical form of the investigational medicinal product - Other significant laboratory abnormalities that the investigator feels may com-promise the patient’s safety by participation in the study - Participation in other clinical trials and observation period of competing trials, respectively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the effect of an 8 weeks oral pentaerithrityltetranitrate therapy in addition to standard long-term CAD medication on flow dependent vasodilation (FMD) in patients suffering from coronary artery disease. ;Secondary Objective: Secondary objectives of the trial include the effects of pentaerithrityltetranitrate therapy on bilirubin, ferritin, hs-CRP plasma concentration, mitochondrial ALDH-2 activity, ENDOPAT 2000 index as well as endothelium-independent nitrogylcerin-induced vasodilation (NMD). ;Primary end point(s): The primary endpoint variable is the absolute change in FMD from baseline to 8 weeks-follow-up. It is formed as FMD at follow-up (V3) – FMD at baseline (V0). FMD is measured in %. | — |
Countries
Germany
Outcome results
None listed