NCT03037047

Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris

Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Green Valley Group of China · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.

Detailed description

This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. The primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4 items), the variation of EKG (level of the S-T segment)., Additional measures of effectiveness include the change from baseline to the end of the treatment in the Seattle Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 28 days. Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the study.

Conditions

• Unstable Angina

Interventions

Type	Name	Description
DRUG	0.9% Sodium Chloride Injection	Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
DRUG	salvianolate injection	Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.

Timeline

• Start date: 2016-05-11
• Primary completion: 2017-12-31
• Completion: 2018-12-31
• First posted: 2017-01-31
• Last updated: 2017-01-31

Locations

1 site across 1 country: China