Essential HypertensionPhase 3PATHNCT01556997

Perindopril Amlodipine for the Treatment of Hypertension

A Phase 3 study testing XOMA 985, Amlodipine Besylate and Perindopril Erbumine in people with Essential Hypertension, run by Symplmed Pharmaceuticals LLC at 48 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

The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Essential Hypertension
What is being tested?: XOMA 985, Amlodipine Besylate and Perindopril Erbumine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 837 participants
Where: 48 sitesUnited States
Study dates: Feb 2012to Feb 2013
Phase: Phase 3
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Essential hypertension
For female subjects, a negative serum pregnancy test
Ability to provide written informed consent

Who cannot join

Night shift workers whose work hours include midnight to 4:00 a.m.
Secondary hypertension
An arm size that precludes the use of the digital blood pressure monitor cuff (arm size > 42 cm)
Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
Female subjects who are pregnant, planning to become pregnant
History of malignancy within 5 years

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Primary aldosteronism
Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve
Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina
Known hypersensitivity to any component of the study drugs
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

48 sites in 1 country.

City, postcode or hospital

48 sites in 1 country

United States48 sites

Study site
Auburn, Maine
Study site
Austin, Texas
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Baltimore, Maryland
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Berlin, New Jersey
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Bristol, Tennessee
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Butte, Montana
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Cincinnati, Ohio
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Columbus, Ohio
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Corpus Christi, Texas
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Dallas, Texas
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DeLand, Florida
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Denver, Colorado
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Eugene, Oregon
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Fort Lauderdale, Florida
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Fort Worth, Texas
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Glendale, Arizona
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Greenbrae, California
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Greensboro, North Carolina
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Gurnee, Illinois
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Hickory, North Carolina
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Houston, Texas
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Huntsville, Alabama
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Indianapolis, Indiana
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Katy, Texas
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Kettering, Ohio
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Los Angeles, California
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Louisville, Kentucky
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Lyndhurst, Ohio
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Marietta, Georgia
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Marion, Ohio
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Metairie, Louisiana
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Miami, Florida
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Mt. Pleasant, South Carolina
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Muscle Shoals, Alabama
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Norfolk, Virginia
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Oklahoma City, Oklahoma
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Olive Branch, Mississippi
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Palm Harbor, Florida
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Port Orange, Florida
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Raleigh, North Carolina
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Richmond, Virginia
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Salt Lake City, Utah
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San Antonio, Texas
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Santa Ana, California
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Simpsonville, South Carolina
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Tulsa, Oklahoma
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Wichita, Kansas
Study site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: Perindopril Amlodipine for the Treatment of Hypertension (PATH): A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Efficacy and Safety of a Fixed-Dose Combination of Perindopril Arginine Plus Amlodipine Besylate Versus Perindopril Erbumine and Amlodipine Besylate in Subjects With Essential Hypertension

The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.

Conditions: Essential Hypertension
Being tested: XOMA 985, Amlodipine Besylate, Perindopril Erbumine
Keywords: Hypertension, Essential Hypertension
Medical subject headings: Essential Hypertension, Hypertension

What participants receive

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

XOMA 985Drug
PERa/AMLb capsule taken once daily by mouth for six weeks
Amlodipine BesylateDrug
AMLb capsule taken once daily by mouth for six weeks
Perindopril ErbumineDrug
PERe capsule taken once daily by mouth for six weeks

Study groups in NCT01556997
Study group	Role	What they receive
XOMA 985	Experimental	fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) Receives: Drug: XOMA 985
Amlodipine Besylate (AMLb)	Active comparator	Not described Receives: Drug: Amlodipine Besylate
Perindopril Erbumine (PERe)	Active comparator	Not described Receives: Drug: Perindopril Erbumine

What is being measured

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

Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
Measured: Day 0 to Day 42

Secondary outcomes (1)

Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
Measured: Day 0 to Day 42

Timeline

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

Feb 2012Feb 2013

First posted19 Mar 2012 (estimated)
Study startFeb 2012
Primary completionFeb 2013
Study completionFeb 2013

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 Essential 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 837 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01556997
Sponsor's protocol ID: X985400
Acronym: PATH
Status last verified: Aug 2015
First submitted: 15 Mar 2012
Last updated: 28 Sep 2015
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

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
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Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
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Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perindopril Amlodipine for the Treatment of Hypertension (PATH): A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Efficacy and Safety of a Fixed-Dose Combination of Perindopril Arginine Plus Amlodipine Besylate Versus Perindopril Erbumine and Amlodipine Besylate in Subjects With Essential Hypertension
ClinicalTrials.gov ID: NCT01556997
Acronym / sponsor ID: PATH / X985400
Conditions: Essential Hypertension
Keywords: Hypertension, Essential Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 837 participants (actual)
Lead sponsor: Symplmed Pharmaceuticals LLCIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 19 Mar 2012 (estimated)
Results: Posted 25 Aug 2015

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 evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
XOMA 985	Experimental	Drug: XOMA 985fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)
Amlodipine Besylate (AMLb)	Active comparator	Drug: Amlodipine Besylate
Perindopril Erbumine (PERe)	Active comparator	Drug: Perindopril Erbumine

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Essential hypertension
For female subjects, a negative serum pregnancy test
Ability to provide written informed consent

Key exclusion criteria (11 listed)

Night shift workers whose work hours include midnight to 4:00 a.m.
Secondary hypertension
An arm size that precludes the use of the digital blood pressure monitor cuff (arm size > 42 cm)
Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
Female subjects who are pregnant, planning to become pregnant

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
XOMA 985PERa/AMLb capsule taken once daily by mouth for six weeks	Drug	XOMA 985
Amlodipine BesylateAMLb capsule taken once daily by mouth for six weeks	Drug	Amlodipine Besylate (AMLb)
Perindopril ErbuminePERe capsule taken once daily by mouth for six weeks	Drug	Perindopril Erbumine (PERe)

Primary outcome

Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
Time frame: Day 0 to Day 42

1 secondary outcome

Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
Time frame: Day 0 to Day 42

Results and safety

Results posted to the registry on 25 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
XOMA 985	279	253
Amlodipine Besylate (AMLb)	280	252
Perindopril Erbumine (PERe)	278	246

Primary outcome: Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).

Time frame: Day 0 to Day 42. Mean (Standard Deviation). Unit: mmHg

Measure	XOMA 985 n = 271	Amlodipine Besylate (AMLb) n = 275	Perindopril Erbumine (PERe) n = 274
Value	-15.7 (8.38)	-13.2 (8.33)	-9.5 (8.77)

XOMA 985 vs Amlodipine Besylate (AMLb) vs Perindopril Erbumine (PERe): p = 0.025, ANCOVA

Population analysed: The Analysis Population for the Primary Outcome (Change from baseline to end of treatment in the mean seated trough cuff diastolic blood pressure (DBP)) consists of the Intent-to-treat population for the study

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
XOMA 985	1 of 279 (0.4%)	75 of 279 (26.9%)	Not reported
Amlodipine Besylate (AMLb)	3 of 280 (1.1%)	68 of 280 (24.3%)	Not reported
Perindopril Erbumine (PERe)	2 of 278 (0.7%)	53 of 278 (19.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Essential Hypertension

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XOMA 985, Amlodipine Besylate and Perindopril Erbumine in people with Essential Hypertension, run by Symplmed Pharmaceuticals LLC at 48 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 11 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 Aug 2015). 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 to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP). (time frame: Day 0 to Day 42). 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 NCT01556997.

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 28 Sep 2015.