Trial Outcomes & Findings for Phase IIb Study of STA-2 in Patients With Chronic Stable Angina (NCT NCT01239511)

Results Overview

the time difference of total exercise time from V2 to V5 compare to placebo

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

186 participants

Primary outcome timeframe

6 weeks after the first exercise tolerance testing is conducted

Results posted on

2014-08-27

Participant Flow

The recruitment period was from Nov. 2010 through Apr. 2012. There are 5 study sites participated in this study, including National Taiwan University Hospita, Chi Mei Medical Center, Taipei Veterans General Hospital, Taipei Medical University-Shuang Ho Hospital and Kaohsiung Medical University Chung-Ho emorial Hospital.

In order to ensure the consistency, the difference of total exercise time between V1 and V2 should be less than 20%.

Participant milestones

Participant milestones
Measure	Placebo Group placebo capsule 2# t.i.d./day	Treatment Group A 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)	Treatment Group B 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)	Treatment Group C 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
Overall Study STARTED	47	45	47	47
Overall Study COMPLETED	46	40	43	38
Overall Study NOT COMPLETED	1	5	4	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase IIb Study of STA-2 in Patients With Chronic Stable Angina

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=46 Participants placebo capsule 2# t.i.d./day	Treatment Group A n=43 Participants 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)	Treatment Group B n=42 Participants 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)	Treatment Group C n=37 Participants 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)	Total n=168 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=99 Participants	24 Participants n=107 Participants	30 Participants n=206 Participants	23 Participants n=7 Participants	106 Participants n=31 Participants
Age, Categorical >=65 years	17 Participants n=99 Participants	19 Participants n=107 Participants	12 Participants n=206 Participants	14 Participants n=7 Participants	62 Participants n=31 Participants
Age, Continuous	60.6 years STANDARD_DEVIATION 0.76 • n=99 Participants	62.1 years STANDARD_DEVIATION 10.40 • n=107 Participants	61.4 years STANDARD_DEVIATION 10.57 • n=206 Participants	59.6 years STANDARD_DEVIATION 10.11 • n=7 Participants	61.0 years STANDARD_DEVIATION 10.43 • n=31 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	7 Participants n=107 Participants	8 Participants n=206 Participants	4 Participants n=7 Participants	28 Participants n=31 Participants
Sex: Female, Male Male	37 Participants n=99 Participants	36 Participants n=107 Participants	34 Participants n=206 Participants	33 Participants n=7 Participants	140 Participants n=31 Participants
Region of Enrollment Taiwan	46 participants n=99 Participants	43 participants n=107 Participants	42 participants n=206 Participants	37 participants n=7 Participants	168 participants n=31 Participants

PRIMARY outcome

Timeframe: 6 weeks after the first exercise tolerance testing is conducted

Population: ITT (intend-to-treat) population will be used for analysis

the time difference of total exercise time from V2 to V5 compare to placebo

Outcome measures

Outcome measures
Measure	Placebo Group n=46 Participants placebo capsule 2# t.i.d./day	Treatment Group A n=43 Participants 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)	Treatment Group B n=42 Participants 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)	Treatment Group C n=37 Participants 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
Change in Total Exercise Time (Seconds)	24.3 second Standard Deviation 8.73	18.2 second Standard Deviation 8.95	33.9 second Standard Deviation 9.03	11.9 second Standard Deviation 9.69

Adverse Events

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment Group B

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment Group C

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Group n=47 participants at risk placebo capsule 2# t.i.d./day	Treatment Group A n=45 participants at risk 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)	Treatment Group B n=47 participants at risk 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)	Treatment Group C n=47 participants at risk 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
Gastrointestinal disorders gastrointestinal haemorrhage	0.00% 0/47	0.00% 0/45	2.1% 1/47 • Number of events 1	0.00% 0/47
Cardiac disorders Coronary artery disease	0.00% 0/47	0.00% 0/45	2.1% 1/47 • Number of events 1	0.00% 0/47
Cardiac disorders Angina Pectoris	0.00% 0/47	0.00% 0/45	0.00% 0/47	2.1% 1/47 • Number of events 1
General disorders Pyrexia	0.00% 0/47	0.00% 0/45	2.1% 1/47 • Number of events 1	0.00% 0/47
Hepatobiliary disorders Hepatitis acute	0.00% 0/47	0.00% 0/45	2.1% 1/47 • Number of events 1	0.00% 0/47
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/47	0.00% 0/45	2.1% 1/47 • Number of events 1	0.00% 0/47
Nervous system disorders Headache	0.00% 0/47	0.00% 0/45	2.1% 1/47 • Number of events 1	0.00% 0/47

Other adverse events

Other adverse events
Measure	Placebo Group n=47 participants at risk placebo capsule 2# t.i.d./day	Treatment Group A n=45 participants at risk 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)	Treatment Group B n=47 participants at risk 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)	Treatment Group C n=47 participants at risk 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/47	2.2% 1/45	2.1% 1/47	0.00% 0/47
Skin and subcutaneous tissue disorders pruritus	0.00% 0/47	2.2% 1/45	0.00% 0/47	0.00% 0/47
Psychiatric disorders Insomnia	0.00% 0/47	0.00% 0/45	2.1% 1/47	0.00% 0/47
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/47	0.00% 0/45	0.00% 0/47	2.1% 1/47
Gastrointestinal disorders Abdominal pain upper	0.00% 0/47	0.00% 0/45	0.00% 0/47	2.1% 1/47

Additional Information

Melanie Huang

Sinphar Pharmaceutical Co., Ltd.

Phone: 886-2-27603688

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place