E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stable coronary heart disease. |
Stabile koronare Herzkrankheit. |
|
E.1.1.1 | Medical condition in easily understood language |
Stable coronary heart disease. |
Stabile koronare Herzkrankheit. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068617 |
E.1.2 | Term | Coronary heart disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
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 |
To test the hypothesis that heart rate reduction induced by the I(f)-channel inhibitor ivabradine improves endothelial function and central vascular compliance in patients with chronic stable coronary artery disease. |
Prüfung der Hypothese, ob die Reduktion der Herzfrequenz bei Patienten mit stabiler coronarer Herzerkrankung mittels des I(f) Kanal Hemmers Ivabradin die Endothelfunktion verbessert und die vaskuläre Steifigkeit verringert. |
|
E.2.2 | Secondary objectives of the trial |
No secondary objectives |
Keine sekundären Untersuchungsziele |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male and female patients
-Age > 18 years old
-Resting heart rate ≥ 70 bpm
-Sinus rhythm
-Chronic stable angina pectoris
-Coronary heart disease detected by coronary angiography
-Written informed consent to participate in the study
|
-Männliche und weibliche Patienten (Mindestalter 18 Jahre)
-Ruheherzfrequenz ≥ 70 Schläge pro Minute
-Sinusrhythmus
-Chronisch stabile Angina pectoris
-Angiographisch nachgewiesene koronare Herzerkrankung
-Schriftliche Einverständniserklärung zur Studienteilnahme
|
|
E.4 | Principal exclusion criteria |
-Acute coronary syndrome / myocardial infarction
-CAD treated best by surgical coronary bypass grafting
-Stroke / TIA
-Resting heart rate < 70/min
-Indwelling pacemaker, AICD, metallic implants
-Valvular heart disease with indication for surgical intervention
-Caridac rhythm other than sinus
-Uncontrolled arterial hypertension
-Preexisting medication with study drug
-Symptomatic PAD
-Known diabetes mellitus
-Pre-menopausal women
|
-Akutes Koronarsyndrom / Myokardinfarkt
-Indikation zur operativen koronaren Revaskularisation (Bypass-OP)
-Schlaganfall oder TIA
-Ruheherzfrequenz < 70 Schläge pro Minute
-Vorhandensein eines Herzschrittmachers/AICDs und anderer metallischer Implantate
-Klappenvitium mit Indikation zur Operation
-Jeglicher Rhythmus außer Sinusrhythmus
-Unkontrollierter Hypertonus
-Bereits bestehende Behandlung mit Studienmedikament
-Symptomatische pAVK
-Vorbekannter Diabetes mellitus
-Frauen vor Eintritt in die Menopause
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Aortic distensibility
-Pulse wave velocity
-Brachial endothelial function
|
-Aortale Distensibilität
-Pulswellengeschwindigkeit
-Endothelfunktion |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of all avove mentioned Endpoints at:
-Baseline
-Months 6
-Month 12 |
Auswertung bezüglich aller oben genannter Endpunkte zum Zeitpunkt:
-Monat 0 (Randomisierungsvisite)
-Monat 6
-Monat 12 |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Serum and Plasma markers for oxidative stress and inflammation |
Parameter für oxidativen Stress und Inflammation (Serum/Plasma)
|
|
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 | No |
E.8.1.6 | Cross over | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
End of the trial after 12 month. |
Geplantes Ende der Studie nach 12 Monaten. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |