Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003094-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The primary objective of this study was to investigate whether there is a clinically meaningful effect on QTc change from baseline relative to placebo after administration of 10 mg at steady state in patients with stable CAD (coronary artery disease).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Treatment sequences: A*-B-C-D |
|
| Treatment 2 | Experimental | Treatment sequences: D-A-B-C* |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat (BAY1021189) | Drug | A : 2.5 mg vericiguat A*: 2.5 mg vericiguat B : 5 mg vericiguat C : 10 mg vericiguat C*: 10 mg vericiguat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-matched placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) after 10 mg vericiguat at steady state. | Baseline, day 56 (steady state 10 mg) of vericiguat treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 2.5 mg vericiguat | Baseline and day 1 of vericiguat treatment | |
| Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 5 mg vericiguat | Baseline and day 15 (+/- 3 days) of vericiguat treatment |
Not provided
Inclusion Criteria:
Patients with stable CAD (coronary artery disease) defined by:
Sinus rhythm at screening
Interpretable echocardiographic images
Age: 30 to 80 years
Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg/m²
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsherzzentrum Freiburg - Bad Krozingen | Bad Krozingen | Baden-Wurttemberg | 79189 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37672197 | Derived | Ruehs H, Solms A, Frei M, Becker C, Trujillo ME, Garmann D, Meyer M. Assessing QTc Effects of Vericiguat Using Two Different Concentration-QTc Modeling Approaches. Clin Pharmacokinet. 2023 Nov;62(11):1639-1648. doi: 10.1007/s40262-023-01282-y. Epub 2023 Sep 6. | |
| 36633816 | Derived | Bottcher M, Dungen HD, Corcea V, Donath F, Fuhr R, Gal P, Mikus G, Trenk D, Coenen M, Pires PV, Maschke C, Aliprantis AO, Besche N, Becker C. Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes. Am J Cardiovasc Drugs. 2023 Mar;23(2):145-155. doi: 10.1007/s40256-022-00557-2. Epub 2023 Jan 12. |
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000603960 | vericiguat |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Moxifloxacin | Drug | D: 400 mg moxifloxacin |
|
| Placebo | Drug | A : vericiguat placebo 10 mg A*: vericiguat placebo 10 mg + moxifloxacin placebo B : vericiguat placebo 10 mg C : vericiguat placebo 2.5 mg C*: vericiguat placebo 2.5 mg + moxifloxacin placebo D : vericiguat placebo 2.5 mg + vericiguat placebo 10 mg |
|
| Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 10 mg vericiguat | Baseline and day 29 (+/- 3 days) of vericiguat treatment |
| Time-matched placebo-corrected change from baseline of QTcF after 2.5 mg vericiguat at steady state | Baseline and day 14 (+/- 3 days) of vericiguat treatment (steady state 2.5 mg) |
| Time-matched placebo-corrected change from baseline of QTcF after 5 mg vericiguat at steady state | Baseline and day 28 (+/- 3 days) of vericiguat treatment (steady state 5 mg) |
| Time-matched placebo-corrected change from baseline of QTcF after single dose of moxifloxacin | Baseline and day 8 of the moxifloxacin treatment period |
| Maximum concentration of vericiguat in plasma after first dose (Cmax) | On profile day 1; Timeframe: 0 - 5 hours after dosing |
| Time to maximum concentration of vericiguat in plasma after first dose (tmax) | On profile day 1; Timeframe: 0 - 5 hours after dosing |
| Maximum concentration of vericiguat in plasma after multiple doses (Cmax, md) | On profile days: 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing |
| Time to maximum concentration of vericiguat in plasma after multiple doses (tmax, md) | On profile days: 1, 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing |
| Maximum concentration of moxifloxacin in plasma after single dose (Cmax) | On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing |
| Time to maximum concentration of moxifloxacin in plasma after single dose (tmax) | On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing |
| Number of subjects with treatment-emergent adverse events (TEAEs) | 12 months |
| Universitätsklinikum Heidelberg |
| Heidelberg |
| Baden-Wurttemberg |
| 69120 |
| Germany |
| Medizinische Einrichtungen der Universität Bonn | Bonn | North Rhine-Westphalia | 53105 | Germany |
| SocraTec R&D Clinical Ward | Erfurt | Thuringia | 99084 | Germany |
| Charité Campus Virchow-Klinikum (CVK) | Berlin | 13353 | Germany |
| PAREXEL GmbH | Berlin | 14050 | Germany |
| IMSP Republican Clinical Hospital | Chisinau | MD2025 | Moldova |
| Center for Human Drug Research | Leiden | 2333 CL | Netherlands |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |