E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049194 |
E.1.2 | Term | Stable angina pectoris |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011093 |
E.1.2 | Term | Coronary atherosclerosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects meeting all of the following criteria will be considered for admission to the trial: - Men or women > 35 and < 80 years of age - Documented clinically stable CAD with stable angina pectoris - Ability of subject to understand the character and individual consequences of the clinical trial - Written informed consent must be available before enrollment in the trial - For women with childbearing potential, adequate contraception (oral contraceptives or intrauterine devices) is required.
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E.4 | Principal 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 <30% (as demonstrated within the last 1 year by echocardiography, LV an-giography, MRI or radionuclide ventriculography, respectively) - Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <110 mmHg) - Initiation of any of the following medications within the last 8 weeks: Aspirin, statins, calcium antagonists, ACE-inhibitors or AT1 receptor blockers, hor-mone replacement therapy. Individuals who take any of these drugs longer than 8 weeks can be included in this trial. - Use of Phosphodiesterase-5-inhibitors (Viagra®, Revatio®, Cialis®, Levitra®), dihydroergotamine and nitrates i.e. isosorbidemononitrate, isosorbidedinitrate, nitroglycerin, pentaerithrityltetranitrate or molsidomin within the last two weeks. - Hemodynamically significant aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy (as demonstrated within the last year by echocardiogra-phy, invasive right/ left heart catheterization or MRI, respectively) - Renal dysfunction (plasma creatinine (men: > 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
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E.5 End points |
E.5.1 | 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 %. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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No interim analyses will be performed |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |