HypertensionPhase 2NCT00635232

A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension

A Phase 2 study testing irbesartan and PS433540 in people with Hypertension, run by Ligand Pharmaceuticals at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hypertension
What is being tested?: irbesartan and PS433540
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 261 participants
Where: 40 sitesUnited States
Study dates: Mar 2008to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 two consecutive qualifying visits must be ≤ 10 mmHg.
Women of child-bearing potential (WOCBP) must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year).

Who cannot join

Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular (includes subjects who are known to have coronary artery disease), renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic, neurologic and psychiatric diseases.
History of malignancy other than adequately treated basal cell or squamous cell skin cancer.
Subjects with a history of myocardial infarction or New York Heart Association (NYHA) class II-IV heart failure.
Subjects with a history of cerebrovascular accident or transient ischemic attack.
Subjects with clinically significant cardiac conduction defects, including second or third degree Atrioventricular Block (AV block), left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
Subjects with hemodynamically significant valvular disease.
Subjects with history of type 1 diabetes mellitus and subjects with a history of type 2 diabetes mellitus using antihyperglycemic medication (oral medication, insulin, or exenatide) are excluded.

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Advanced Clinical Research Institute
Anaheim, California, 92801
Associated Pharmaceutical Research Center
Buena Park, California, 90620
Punzi Medical Center
Carrollton, Texas, 75006
Cary Medical Research
Cary, North Carolina, 27518
Metrolina Medical Research
Charlotte, North Carolina, 28209
Cedar Crosse Research Center
Chicago, Illinois, 60607
The Lindner Center
Cincinnati, Ohio, 45219
Q Clinical Research
Decatur, Georgia, 30035
Univ. Clinical Research Deland, LLC.
DeLand, Florida, 32720
Delaware Smith Clinic
Delaware, Ohio, 43015
Brandywine Clinical Research Center
Downingtown, Pennsylvania, 19335
Allan Graff
Fort Lauderdale, Florida, 33308
Unifour Medical Research NC
Hickory, North Carolina, 28601
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Northstate Clinical Research
Lenoir, North Carolina, 28645
Clinical Trials Research CA
Lincoln, California, 95648
Long Beach Center for Clinical Research
Long Beach, California, 90806
National Research Institute
Los Angeles, California, 90057
Gemini Scientific LLC
Madison, Wisconsin, 53719
Smith Clinic
Marion, Ohio, 43302
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502
COR Clinical Research, L.L.C
Oklahoma City, Oklahoma, 73103
MD Medical Research
Oxon Hill, Maryland, 20745
Advanced Clinical Research 1000 Forrest Place Suite 2 Pell City
Pell City, Alabama, 35128
Hypertension & Nephrology Inc
Providence, Rhode Island, 02904
Triangle Medical Research NC
Raleigh, North Carolina, 27609
Superior Regional Research, LLC
Sacramento, California, 95825
Crescent Medical Research
Salisbury, North Carolina, 28144
Innovative Clinical Trials
San Antonio, Texas, 78229
IMED Research PA
San Antonio, Texas, 78258
North County Medical
Sebastian, Florida, 32958
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Premiere Pharmaceutical Research, LLC
Tempe, Arizona, 85282
Genova Clinical Research AZ
Tucson, Arizona, 85741
Orange County Research Center
Tustin, California, 92780
Westlake Medical Center
Westlake Village, California, 91361
New Hanover Medical Rersearch
Wilmington, North Carolina, 28401
Peidmont Medical Research Associates
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo And Active-Controlled, Parallel Group Study To Evaluate The Dose-Related Efficacy And Safety Of PS433540 In Subjects With Hypertension

The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients will be entered into the treatment phase of the study and be given PS433540.

Conditions: Hypertension
Being tested: irbesartan, placebo, PS433540
Keywords: Hypertension, High Blood Pressure
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

irbesartanDrug
Also called Avapro
300 mg (2 x 150 mg capsules) once daily for 12 weeks
placeboDrug
placebo capsules once daily for 12 weeks
PS433540Drug
200 mg (2 x 100 mg capsules) once daily for 12 weeks
PS433540Drug
400 mg (4 x 100 mg capsules) once daily for 12 weeks
PS433540Drug
800 mg (8 x 100 mg capsules) once daily for 12 weeks

Study groups in NCT00635232
Study group	Role	What they receive
Irbesartan 300mg	Active comparator	Irbesartan 300 mg once daily Receives: Drug: irbesartan
Placebo	Placebo comparator	Blinded Placebo Treatment Receives: Drug: placebo
PS433540 200mg	Experimental	PS433540 200mg once daily Receives: Drug: PS433540
PS433540 400mg	Experimental	PS433540 400mg once daily Receives: Drug: PS433540
PS433540 800mg	Experimental	PS433540 800mg once daily Receives: Drug: PS433540

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Secondary outcomes (2)

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.
Measured: 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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Dec 2008

First posted13 Mar 2008 (estimated)
Study startMar 2008
Primary completionNov 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00635232
Sponsor's protocol ID: PCO-C-006
Status last verified: Sep 2011
First submitted: 6 Mar 2008
Last updated: 16 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo And Active-Controlled, Parallel Group Study To Evaluate The Dose-Related Efficacy And Safety Of PS433540 In Subjects With Hypertension
ClinicalTrials.gov ID: NCT00635232
Acronym / sponsor ID: PCO-C-006
Conditions: Hypertension
Keywords: Hypertension, High Blood Pressure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Nov 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 13 Mar 2008 (estimated)
Results: Posted 13 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Irbesartan 300mg	Active comparator	Drug: irbesartanIrbesartan 300 mg once daily
Placebo	Placebo comparator	Drug: placeboBlinded Placebo Treatment
PS433540 200mg	Experimental	Drug: PS433540PS433540 200mg once daily
PS433540 400mg	Experimental	Drug: PS433540PS433540 400mg once daily
PS433540 800mg	Experimental	Drug: PS433540PS433540 800mg once daily

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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 two consecutive qualifying visits must be ≤ 10 mmHg.
Women of child-bearing potential (WOCBP) must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year).

Key exclusion criteria (7 listed)

Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular (includes subjects who are known to have coronary artery disease), renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic, neurologic and psychiatric diseases.
History of malignancy other than adequately treated basal cell or squamous cell skin cancer.
Subjects with a history of myocardial infarction or New York Heart Association (NYHA) class II-IV heart failure.
Subjects with a history of cerebrovascular accident or transient ischemic attack.
Subjects with clinically significant cardiac conduction defects, including second or third degree Atrioventricular Block (AV block), left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
irbesartanAlso: Avapro300 mg (2 x 150 mg capsules) once daily for 12 weeks	Drug	Irbesartan 300mg
placeboplacebo capsules once daily for 12 weeks	Drug	Placebo
PS433540200 mg (2 x 100 mg capsules) once daily for 12 weeks	Drug	PS433540 200mg
PS433540400 mg (4 x 100 mg capsules) once daily for 12 weeks	Drug	PS433540 400mg
PS433540800 mg (8 x 100 mg capsules) once daily for 12 weeks	Drug	PS433540 800mg

Primary outcome

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.
Time frame: 12 weeks

2 secondary outcomes

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.
Time frame: 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.
Time frame: 12 weeks

Results and safety

Results posted to the registry on 13 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Irbesartan 300mg	58	44
Placebo	59	39
PS433540 200mg	58	55
PS433540 400mg	58	48
PS433540 800mg	28	20

Primary outcome: 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.

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Irbesartan 300mg n = 58	Placebo n = 59	PS433540 200mg n = 58	PS433540 400mg n = 58	PS433540 800mg n = 28
Value	-10.7 (14.32)	1.8 (14.16)	-13.2 (13.61)	-14.2 (11.90)	-23.4 (18.70)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Irbesartan 300mg	0 of 58 (0%)	19 of 58 (32.8%)	Not reported
Placebo	0 of 59 (0%)	20 of 59 (33.9%)	Not reported
PS433540 200mg	0 of 58 (0%)	10 of 58 (17.2%)	Not reported
PS433540 400mg	1 of 58 (1.7%)	25 of 58 (43.1%)	Not reported
PS433540 800mg	0 of 28 (0%)	17 of 28 (60.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Not yet recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rene Belder, MD study director

Ligand Pharmaceuticals

Joel Neutel, MD principal investigator

Orange County Research Center

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irbesartan and PS433540 in people with Hypertension, run by Ligand Pharmaceuticals at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00635232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2011.