Trial Outcomes & Findings for A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension (NCT NCT00635232)
NCT ID: NCT00635232
Last Updated: 2011-09-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
261 participants
Primary outcome timeframe
12 weeks
Results posted on
2011-09-16
Participant Flow
All subjects were weaned off all antihypertensive medication prior to be entered into a 4-week single-blind placebo run-in period. Subjects had to have eligible Seated systolic and diastolic BP measurements during the single-blind placebo run-in phase to be eligible for the double blind portion of the study.
Participant milestones
| Measure |
Irbesartan 300mg
Irbesartan 300 mg once daily
|
Placebo
Blinded Placebo Treatment
|
PS433540 200mg
PS433540 200mg once daily
|
PS433540 400mg
PS433540 400mg once daily
|
PS433540 800mg
PS433540 800mg once daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
58
|
58
|
28
|
|
Overall Study
COMPLETED
|
44
|
39
|
55
|
48
|
20
|
|
Overall Study
NOT COMPLETED
|
14
|
20
|
3
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
Baseline characteristics by cohort
| Measure |
Irbesartan 300mg
n=58 Participants
Irbesartan 300 mg once daily
|
Placebo
n=59 Participants
Blinded Placebo Treatment
|
PS433540 200mg
n=58 Participants
PS433540 200mg once daily
|
PS433540 400mg
n=58 Participants
PS433540 400mg once daily
|
PS433540 800mg
n=28 Participants
PS433540 800mg once daily
|
Total
n=261 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
231 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
|
Age Continuous
|
51.5 years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 8.12 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 10.58 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 10.71 • n=4 Participants
|
51.4 years
STANDARD_DEVIATION 9.92 • n=21 Participants
|
52.9 years
STANDARD_DEVIATION 9.66 • n=10 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
123 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
138 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
59 participants
n=7 Participants
|
58 participants
n=5 Participants
|
58 participants
n=4 Participants
|
28 participants
n=21 Participants
|
261 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The primary efficacy population was the Full Analysys Set (FAS) population= all randomized subjects who took at least one dose of the assigned study drug and had both baseline and post-baseline mean seated SBP. Both LOCF and observed-data set approach were performed.
Outcome measures
| Measure |
Irbesartan 300mg
n=58 Participants
|
Placebo
n=59 Participants
|
PS433540 200mg
n=58 Participants
|
PS433540 400mg
n=58 Participants
|
PS433540 800mg
n=28 Participants
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.
|
-10.7 mm Hg
Standard Deviation 14.32
|
1.8 mm Hg
Standard Deviation 14.16
|
-13.2 mm Hg
Standard Deviation 13.61
|
-14.2 mm Hg
Standard Deviation 11.90
|
-23.4 mm Hg
Standard Deviation 18.70
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Irbesartan 300mg
n=58 Participants
|
Placebo
n=59 Participants
|
PS433540 200mg
n=58 Participants
|
PS433540 400mg
n=58 Participants
|
PS433540 800mg
n=28 Participants
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.
|
-7.1 mm Hg
Standard Deviation 9.19
|
0.2 mm Hg
Standard Deviation 9.68
|
-7.2 mm Hg
Standard Deviation 8.34
|
-9.2 mm Hg
Standard Deviation 9.10
|
-14.3 mm Hg
Standard Deviation 10.53
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (LOCF)
Outcome measures
| Measure |
Irbesartan 300mg
n=58 Participants
|
Placebo
n=59 Participants
|
PS433540 200mg
n=58 Participants
|
PS433540 400mg
n=58 Participants
|
PS433540 800mg
n=28 Participants
|
|---|---|---|---|---|---|
|
The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.
|
17 participants
|
5 participants
|
21 participants
|
28 participants
|
16 participants
|
Adverse Events
Irbesartan 300mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
PS433540 200mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
PS433540 400mg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
PS433540 800mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Irbesartan 300mg
n=58 participants at risk
Irbesartan 300 mg once daily
|
Placebo
n=59 participants at risk
Blinded Placebo Treatment
|
PS433540 200mg
n=58 participants at risk
PS433540 200mg once daily
|
PS433540 400mg
n=58 participants at risk
PS433540 400mg once daily
|
PS433540 800mg
n=28 participants at risk
PS433540 800mg once daily
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
1.7%
1/58 • Number of events 1
|
0.00%
0/28
|
Other adverse events
| Measure |
Irbesartan 300mg
n=58 participants at risk
Irbesartan 300 mg once daily
|
Placebo
n=59 participants at risk
Blinded Placebo Treatment
|
PS433540 200mg
n=58 participants at risk
PS433540 200mg once daily
|
PS433540 400mg
n=58 participants at risk
PS433540 400mg once daily
|
PS433540 800mg
n=28 participants at risk
PS433540 800mg once daily
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/58
|
1.7%
1/59
|
1.7%
1/58
|
0.00%
0/58
|
7.1%
2/28
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/58
|
0.00%
0/59
|
1.7%
1/58
|
1.7%
1/58
|
3.6%
1/28
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/58
|
0.00%
0/59
|
1.7%
1/58
|
1.7%
1/58
|
7.1%
2/28
|
|
Nervous system disorders
Dizziness
|
3.4%
2/58
|
3.4%
2/59
|
0.00%
0/58
|
3.4%
2/58
|
10.7%
3/28
|
|
Eye disorders
Eye Disorders
|
0.00%
0/58
|
5.1%
3/59
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/28
|
|
General disorders
Fatigue
|
5.2%
3/58
|
1.7%
1/59
|
0.00%
0/58
|
6.9%
4/58
|
0.00%
0/28
|
|
Gastrointestinal disorders
Feces Discoloured
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
0.00%
0/58
|
3.6%
1/28
|
|
Vascular disorders
Flushing
|
0.00%
0/58
|
0.00%
0/59
|
1.7%
1/58
|
0.00%
0/58
|
3.6%
1/28
|
|
Investigations
Haemoglobin abnormal
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
0.00%
0/58
|
3.6%
1/28
|
|
Nervous system disorders
Headache
|
6.9%
4/58
|
16.9%
10/59
|
0.00%
0/58
|
5.2%
3/58
|
7.1%
2/28
|
|
Vascular disorders
Hot Flush
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
1.7%
1/58
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.4%
2/58
|
0.00%
0/59
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/28
|
|
Vascular disorders
Hypertension
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
0.00%
0/58
|
3.6%
1/28
|
|
Vascular disorders
Hypotension
|
1.7%
1/58
|
0.00%
0/59
|
1.7%
1/58
|
3.4%
2/58
|
3.6%
1/28
|
|
Infections and infestations
Influenza
|
1.7%
1/58
|
1.7%
1/59
|
0.00%
0/58
|
3.4%
2/58
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications
|
3.4%
2/58
|
3.4%
2/59
|
3.4%
2/58
|
6.9%
4/58
|
0.00%
0/28
|
|
Nervous system disorders
Migraine
|
3.4%
2/58
|
5.1%
3/59
|
0.00%
0/58
|
3.4%
2/58
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
3.4%
2/58
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/58
|
0.00%
0/59
|
1.7%
1/58
|
3.4%
2/58
|
0.00%
0/28
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/58
|
0.00%
0/59
|
3.4%
2/58
|
1.7%
1/58
|
3.6%
1/28
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58
|
0.00%
0/59
|
0.00%
0/58
|
1.7%
1/58
|
7.1%
2/28
|
|
General disorders
Oedema Peripheral
|
3.4%
2/58
|
1.7%
1/59
|
3.4%
2/58
|
6.9%
4/58
|
10.7%
3/28
|
|
General disorders
Pyrexia
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
0.00%
0/58
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/58
|
1.7%
1/59
|
0.00%
0/58
|
0.00%
0/58
|
3.6%
1/28
|
|
Infections and infestations
Sinusitis
|
3.4%
2/58
|
1.7%
1/59
|
3.4%
2/58
|
0.00%
0/58
|
0.00%
0/28
|
|
Psychiatric disorders
Stress
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
0.00%
0/58
|
3.6%
1/28
|
|
Infections and infestations
Tooth Abcess
|
1.7%
1/58
|
0.00%
0/59
|
0.00%
0/58
|
3.4%
2/58
|
3.6%
1/28
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.7%
1/58
|
3.4%
2/59
|
0.00%
0/58
|
1.7%
1/58
|
0.00%
0/28
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/58
|
5.1%
3/59
|
0.00%
0/58
|
0.00%
0/58
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.4%
2/58
|
0.00%
0/59
|
0.00%
0/58
|
0.00%
0/58
|
0.00%
0/28
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58
|
0.00%
0/59
|
0.00%
0/58
|
0.00%
0/58
|
3.6%
1/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place