Trial · NCT00635232
A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
NCT00635232, Phase 2, Completed, Ligand Pharmaceuticals; results first posted 2011-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension. Trials, record NCT00635232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00635232
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
- NCT number
- NCT00635232
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 261 participants, actual
- Lead sponsor
- Ligand Pharmaceuticals
- Conditions
- Hypertension
- Interventions
- irbesartan, placebo, PS433540, PS433540, PS433540
- First posted
- 2008-03-13
- Last updated
- 2011-09-16
- Results first posted
- 2011-09-13
- Limitations and caveats
The 800mg dose level was discontinued from further enrollment per protocol amendment due to findings from another PS433540 trial that suggested clinical benefit beyond 500mg was expected to be limited.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 12 weeks | |
| Secondary | 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. | 12 weeks | |
| Secondary | 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. | 12 weeks |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | 12 weeks | 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. | mm Hg | MEAN |
| SECONDARY | 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. | 12 weeks | mm Hg | MEAN | |
| SECONDARY | 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. | 12 weeks | Full analysis set (LOCF) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Irbesartan 300mg | -10.7 | Standard Deviation 14.32 | mm Hg | |
| 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. | Placebo | 1.8 | Standard Deviation 14.16 | mm Hg | |
| 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. | PS433540 200mg | -13.2 | Standard Deviation 13.61 | mm Hg | |
| 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. | PS433540 400mg | -14.2 | Standard Deviation 11.90 | mm Hg | |
| 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. | PS433540 800mg | -23.4 | Standard Deviation 18.70 | mm Hg | |
| 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. | Irbesartan 300mg | -7.1 | Standard Deviation 9.19 | mm Hg | |
| 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. | Placebo | 0.2 | Standard Deviation 9.68 | mm Hg | |
| 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. | PS433540 200mg | -7.2 | Standard Deviation 8.34 | mm Hg | |
| 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. | PS433540 400mg | -9.2 | Standard Deviation 9.10 | mm Hg | |
| 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. | PS433540 800mg | -14.3 | Standard Deviation 10.53 | mm Hg |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Irbesartan 300mg | 58 | |
| Overall Study | STARTED | Placebo | 59 | |
| Overall Study | STARTED | PS433540 200mg | 58 | |
| Overall Study | STARTED | PS433540 400mg | 58 | |
| Overall Study | STARTED | PS433540 800mg | 28 | |
| Overall Study | COMPLETED | Irbesartan 300mg | 44 | |
| Overall Study | COMPLETED | Placebo | 39 | |
| Overall Study | COMPLETED | PS433540 200mg | 55 | |
| Overall Study | COMPLETED | PS433540 400mg | 48 | |
| Overall Study | COMPLETED | PS433540 800mg | 20 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Irbesartan 300mg | 0 | 58 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 59 | |
| other | Abdominal Pain | Gastrointestinal disorders | PS433540 200mg | 1 | 58 | |
| other | Abdominal Pain | Gastrointestinal disorders | PS433540 400mg | 0 | 58 | |
| other | Abdominal Pain | Gastrointestinal disorders | PS433540 800mg | 2 | 28 | |
| other | Dermatitis Contact | Skin and subcutaneous tissue disorders | Irbesartan 300mg | 0 | 58 | |
| other | Dermatitis Contact | Skin and subcutaneous tissue disorders | Placebo | 0 | 59 | |
| other | Dermatitis Contact | Skin and subcutaneous tissue disorders | PS433540 200mg | 1 | 58 | |
| other | Dermatitis Contact | Skin and subcutaneous tissue disorders | PS433540 400mg | 1 | 58 | |
| other | Dermatitis Contact | Skin and subcutaneous tissue disorders | PS433540 800mg | 1 | 28 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Irbesartan 300mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PS433540 200mg | ||
| Total, all-cause mortality | PS433540 400mg | ||
| Total, all-cause mortality | PS433540 800mg | ||
| Total, other adverse events | Irbesartan 300mg | 19 | 58 |
| Total, other adverse events | Placebo | 20 | 59 |
| Total, other adverse events | PS433540 200mg | 10 | 58 |
| Total, other adverse events | PS433540 400mg | 25 | 58 |
| Total, other adverse events | PS433540 800mg | 17 | 28 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00635232
GET https://conductscience.org/api/trials/v1/NCT00635232/events?page=2