HypertensionPhase 2NCT00522925
A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension
A Phase 2 study testing PS433540 in people with Hypertension, run by Ligand Pharmaceuticals at 15 sites in United States.
Trial summary
The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- PS433540
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2007to May 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 30 - 80 years
- Mean seated Systolic Blood Pressure (SBP) ≥ 150 - ≤ 179 mmHg and mean seated DBP < 110 mmHg at two consecutive qualifying visits. The mean difference in SBP between the two consecutive qualifying visits must be ≤ 10 mmHg.
- Mean daytime (8AM - 4PM) ambulatory SBP must be between ≥ 140 - ≤ 179 mmHg and mean daytime (8AM - 4PM) Diastolic Blood Pressure (DBP) ≤ 110 mmHg
- Subjects must have a usual daytime schedule. Night shift workers are excluded from participation.
- Women of child-bearing potential (WOCBP) and male subjects 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, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
- Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or New York Heart Association (NYHA) class II-IV heart failure within the last 6 months.
- Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
- Subjects with diabetes mellitus (type I and type II).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Punzi Medical Center
Carrolton, Texas, 75006
Cedar Crosse Research Center
Chicago, Illinois, 60607
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
University Clinical Research Deland, LLC
DeLand, Florida, 32720
Alan Graff, MD PA
Fort Lauderdale, Florida, 33308
Clinical Trials Research
Lincoln, California, 95648
Long Beach Center for Clinical Research
Long Beach, California, 90806
National Research Institute
Los Angeles, California, 90057
Gemini Scientific
Madison, Wisconsin, 53719
Orland Primary Care Specialists
Orland Park, Illinois, 60467
MD Medical Research
Oxon Hill, Maryland, 20745
Sacramento Research Medical Group
Sacramento, California, 95825
Premiere Pharmaceutical Research, LLC
Tempe, Arizona, 85282
Orange County Research Center
Tustin, California, 92780
Westlake Medical Center
Westlake Village, California, 91361
About this study
Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of a Novel Dual Angiotensin and Endothelin Receptor Antagonist (PS433540) in Subjects With Stage I and II Hypertension
The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.
- Conditions
- Hypertension
- Being tested
- PS433540, placebo
- 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.
PS433540Drug
200mg capsule, once daily for 28 days
placeboDrug
placebo capsule, once daily for 28 days
PS433540Drug
500mg capsule, once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Matching Placebo Receives: Drug: placebo |
| 2 | Experimental | Not described Receives: Drug: PS433540 |
| 3 | Experimental | Not described 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 24-hour Ambulatory Systolic Blood Pressure
Measured: 4 weeks of treatment with PS43540
Secondary outcomes (2)
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure
Measured: 4 weeks of treatment with PS43540
Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure
Measured: 4 weeks of treatment with PS43540
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionMay 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel M Neutel, MD, Principal investigator, Integrium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522925
- Sponsor's protocol ID
- PCO-C-008
- Status last verified
- Sep 2011
- First submitted
- 29 Aug 2007
- Last updated
- 16 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of a Novel Dual Angiotensin and Endothelin Receptor Antagonist (PS433540) in Subjects With Stage I and II Hypertension
- ClinicalTrials.gov ID
- NCT00522925
- Acronym / sponsor ID
- PCO-C-008
- Conditions
- Hypertension
- Keywords
- hypertension, high blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Posted 14 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboMatching Placebo |
| 2 | Experimental | Drug: PS433540 |
| 3 | Experimental | Drug: PS433540 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females 30 - 80 years
- Mean seated Systolic Blood Pressure (SBP) ≥ 150 - ≤ 179 mmHg and mean seated DBP < 110 mmHg at two consecutive qualifying visits. The mean difference in SBP between the two consecutive qualifying visits must be ≤ 10 mmHg.
- Mean daytime (8AM - 4PM) ambulatory SBP must be between ≥ 140 - ≤ 179 mmHg and mean daytime (8AM - 4PM) Diastolic Blood Pressure (DBP) ≤ 110 mmHg
- Subjects must have a usual daytime schedule. Night shift workers are excluded from participation.
- Women of child-bearing potential (WOCBP) and male subjects must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year)
Key exclusion criteria (4 listed)
- Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
- Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or New York Heart Association (NYHA) class II-IV heart failure within the last 6 months.
- Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
- Subjects with diabetes mellitus (type I and type II).
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 |
|---|---|---|
| PS433540200mg capsule, once daily for 28 days | Drug | 2 |
| placeboplacebo capsule, once daily for 28 days | Drug | 1 |
| PS433540500mg capsule, once daily for 28 days | Drug | 3 |
Primary outcome
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure
Time frame: 4 weeks of treatment with PS43540
2 secondary outcomes
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure
Time frame: 4 weeks of treatment with PS43540
Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure
Time frame: 4 weeks of treatment with PS43540
Results and safety
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.
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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.
Joel M Neutel, MD principal investigator
Integrium
15 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 PS433540 in people with Hypertension, run by Ligand Pharmaceuticals at 15 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 5 inclusion and 4 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 15 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 14 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 24-hour Ambulatory Systolic Blood Pressure (time frame: 4 weeks of treatment with PS43540). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.