Trial Outcomes & Findings for A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension (NCT NCT00522925)
NCT ID: NCT00522925
Last Updated: 2011-09-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
280 participants
Primary outcome timeframe
4 weeks of treatment with PS43540
Results posted on
2011-09-16
Participant Flow
Participant milestones
| Measure |
1- Placebo
Placebo
|
2- PS433540 200mg
200mg daily for 4 weeks
|
3- PS433540 500mg
500mg once daily for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
39
|
38
|
|
Overall Study
COMPLETED
|
28
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension
Baseline characteristics by cohort
| Measure |
1- Placebo
n=36 Participants
Placebo
|
2- PS433540 200mg
n=39 Participants
200mg daily for 4 weeks
|
3- PS433540 500mg
n=38 Participants
500mg once daily for 4 weeks
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age Continuous
|
58.4 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 8.72 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 9.87 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 8.84 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
39 participants
n=7 Participants
|
38 participants
n=5 Participants
|
113 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks of treatment with PS43540Outcome measures
| Measure |
1- Placebo
n=36 Participants
Placebo
|
2- PS433540 200mg
n=39 Participants
200mg daily for 4 weeks
|
3- PS433540 500mg
n=38 Participants
500mg once daily for 4 weeks
|
|---|---|---|---|
|
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure
|
-0.3 mmHg
Interval -4.8 to 4.2
|
-11.9 mmHg
Interval -15.3 to -8.6
|
-15.3 mmHg
Interval -18.8 to -11.8
|
SECONDARY outcome
Timeframe: 4 weeks of treatment with PS43540Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks of treatment with PS43540Outcome measures
Outcome data not reported
Adverse Events
1- Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
2- PS433540 200mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
3- PS433540 500mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1- Placebo
n=36 participants at risk
Placebo
|
2- PS433540 200mg
n=39 participants at risk
200mg daily for 4 weeks
|
3- PS433540 500mg
n=38 participants at risk
500mg once daily for 4 weeks
|
|---|---|---|---|
|
Cardiac disorders
Syncope
|
2.8%
1/36 • Number of events 1
|
0.00%
0/39
|
0.00%
0/38
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/36
|
2.6%
1/39 • Number of events 1
|
0.00%
0/38
|
Other adverse events
| Measure |
1- Placebo
n=36 participants at risk
Placebo
|
2- PS433540 200mg
n=39 participants at risk
200mg daily for 4 weeks
|
3- PS433540 500mg
n=38 participants at risk
500mg once daily for 4 weeks
|
|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.8%
1/36 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
|
Nervous system disorders
Headache
|
11.1%
4/36 • Number of events 6
|
5.1%
2/39 • Number of events 2
|
7.9%
3/38 • Number of events 4
|
|
General disorders
Fatigue
|
2.8%
1/36 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
3/36 • Number of events 3
|
2.6%
1/39 • Number of events 1
|
0.00%
0/38
|
|
Investigations
Blood Pressure Increase
|
2.8%
1/36 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
0.00%
0/38
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
2/36 • Number of events 2
|
2.6%
1/39 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Cardiac disorders
Oedema Peripheral
|
2.8%
1/36 • Number of events 2
|
0.00%
0/39
|
2.6%
1/38 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
2.8%
1/36 • Number of events 1
|
0.00%
0/39
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Swelling
|
0.00%
0/36
|
0.00%
0/39
|
2.6%
1/38 • Number of events 1
|
|
Psychiatric disorders
Confusional State
|
5.6%
2/36 • Number of events 2
|
0.00%
0/39
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
2/36 • Number of events 2
|
0.00%
0/39
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/36
|
0.00%
0/39
|
2.6%
1/38 • Number of events 1
|
Additional Information
Ram Kapil, PhD/ Sr. Director, Clinical Pharmacology
Ligand Pharmaceuticals, Inc.
Phone: 858-550-7603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place