A Randomized, Double-blind, Placebo-controlled, Three-arm Parallel-group, Multi-centre Phase III Clinical Study to Confirm the Anti-anginal Effect of T89 in Patients with Stable Angina (ORESA Study)

Conditions

Stable Angina Pectoris

Brief summary

Efficacy endpoint: Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 57., Safety endpoints: Frequency and severity of adverse events and serious adverse events, Safety endpoints: Notable laboratory abnormalities which are treatment-emergent

Detailed description

Efficacy endpoints: The trend of TED changes over time (Slope) from Day 1 to Day 57., Percent change in the average frequency of angina episodes (average over 14 days) from baseline [Day -14 to 1] to the end of double-blind treatment period [Day 43 to 57]., Percent change in the average on-demand consumption of short-acting nitroglycerin (average over 14 days) from baseline [Day -14 to 1] to end of double-blind treatment period [Day 43 to 57]., Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 43;, Percent change in the average frequency of angina episodes (average over 14 days) from baseline [Day -14 to 1] to the end of double-blind treatment period [Day 29 to 43]., Change in time to the onset of angina during ETT from baseline to Day 57, Change in time to the onset of 1 mm ST depression during ETT from baseline to Day 57

Related papers

No related papers found yet.

Interventions

DRUGT89 Placebo; capsules contain brown coated dripping pills.

DRUGNitroglycerin Orifarm 0

DRUG5 mg tabletes lietošanai zem mēles

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Efficacy endpoint: Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 57., Safety endpoints: Frequency and severity of adverse events and serious adverse events, Safety endpoints: Notable laboratory abnormalities which are treatment-emergent	—

Secondary

Measure	Time frame
Efficacy endpoints: The trend of TED changes over time (Slope) from Day 1 to Day 57., Percent change in the average frequency of angina episodes (average over 14 days) from baseline [Day -14 to 1] to the end of double-blind treatment period [Day 43 to 57]., Percent change in the average on-demand consumption of short-acting nitroglycerin (average over 14 days) from baseline [Day -14 to 1] to end of double-blind treatment period [Day 43 to 57]., Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 43;, Percent change in the average frequency of angina episodes (average over 14 days) from baseline [Day -14 to 1] to the end of double-blind treatment period [Day 29 to 43]., Change in time to the onset of angina during ETT from baseline to Day 57, Change in time to the onset of 1 mm ST depression during ETT from baseline to Day 57	—

Measure

Time frame

Efficacy endpoints: The trend of TED changes over time (Slope) from Day 1 to Day 57., Percent change in the average frequency of angina episodes (average over 14 days) from baseline [Day -14 to 1] to the end of double-blind treatment period [Day 43 to 57]., Percent change in the average on-demand consumption of short-acting nitroglycerin (average over 14 days) from baseline [Day -14 to 1] to end of double-blind treatment period [Day 43 to 57]., Change in symptom-limited total exercise duration (TED) at trough drug levels on standard Bruce protocol from baseline to Day 43;, Percent change in the average frequency of angina episodes (average over 14 days) from baseline [Day -14 to 1] to the end of double-blind treatment period [Day 29 to 43]., Change in time to the onset of angina during ETT from baseline to Day 57, Change in time to the onset of 1 mm ST depression during ETT from baseline to Day 57

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Countries

Bulgaria, Poland, Romania, Slovakia

Outcome results

None listed