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PS433540

Phase 2

Hypertension | Small molecule | Cardiovascular |Ligand Pharmaceuticals Incorporated|Last Updated: Sep 16, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment541

FDA Designations

No designations recorded

Clinical trial landscape

PS433540 · 2 trials · 1 indication

Phase 2 2
NCT00635232A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With HypertensionHypertension
COMPLETED261 Analytics
NCT00522925A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat HypertensionHypertension
COMPLETED280 Analytics
PHASE2COMPLETED
A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
HypertensionUnlock trial analytics
PHASE2COMPLETED
A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure
4 weeks of treatment with PS43540

Secondary Endpoints

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
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
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure
4 weeks of treatment with PS43540
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Irbesartan 300mgACTIVE_COMPARATORIrbesartan 300 mg once daily
PlaceboPLACEBO_COMPARATORBlinded Placebo Treatment
PS433540 200mgEXPERIMENTALPS433540 200mg once daily
PS433540 400mgEXPERIMENTALPS433540 400mg once daily
PS433540 800mgEXPERIMENTALPS433540 800mg once daily
1PLACEBO_COMPARATORMatching Placebo
2EXPERIMENTAL -
3EXPERIMENTAL -

Interventions

NameTypeDescription
irbesartanDRUG300 mg (2 x 150 mg capsules) once daily for 12 weeks
placeboDRUGplacebo capsules once daily for 12 weeks
PS433540DRUG200 mg (2 x 100 mg capsules) once daily for 12 weeks
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Males or females 18 - 70 years * Mean seated Systolic Blood Pressure (SBP) ≥ 140 mmHg and \< 180 mmHg and mean seated Diastolic Blood Pressure (DBP) \> 90 and \< 109 mmHg at two consecutive qualifying visits (Visits 3/3.5 and Visit 4). The mean difference in DBP between the tw...

Countries:United States
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Frequently asked questions about PS433540

What is PS433540 used for?

PS433540 is an investigational small molecule being developed for the treatment of hypertension, a cardiovascular condition. It is currently in Phase 2 clinical development and has not been approved by the FDA. Two Phase 2 trials have been completed to evaluate its safety and efficacy in patients with hypertension.

Who makes PS433540?

PS433540 is being developed by Ligand Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol LGND. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating hypertension.

What phase is PS433540 in?

PS433540 is in Phase 2 clinical development. Two Phase 2 trials have been completed, both focusing on the treatment of hypertension. The drug is still investigational and has not received FDA approval. Its safety and efficacy are being evaluated in clinical studies.

What clinical trials is PS433540 in?

PS433540 has been studied in two completed Phase 2 clinical trials: NCT00522925, which enrolled 280 participants with hypertension in the United States, and NCT00635232, which enrolled 261 participants. Both trials were randomized, double-blind, and placebo-controlled, with a combined enrollment of 541 participants.

Is PS433540 the same as any other drug?

PS433540 is the primary name used in clinical trials for this investigational hypertension treatment. No alternative names have been reported in the available clinical trial data. The drug is being developed by Ligand Pharmaceuticals and is currently in Phase 2 development.