HealthyPhase 1NCT02230878

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants

A Phase 1 study testing JNJ-42847922 5 mg, JNJ-42847922 10 mg and JNJ-42847922 20 mg in people with Healthy, run by Janssen-Cilag International NV at 1 site in Germany.

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 this study is to investigate the safety, tolerability, pharmacokinetic (the study of the way a drug enters and leaves the blood and tissues over time), dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how drugs act on the body) and sedative effects of JNJ-42847922 in… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-42847922 5 mg, JNJ-42847922 10 mg and JNJ-42847922 20 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteGermany
Study dates: May 2014to Nov 2014
Phase: Phase 1
Are there results?: None posted in the registry

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Women should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years
Body Mass Index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive (BMI=weight/height^2)
Participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase
Non-smokers (not smoked for 6 months prior to screening)
Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

Who cannot join

Clinically significant abnormal values for hematology, serum chemistry or urinalysis at screening or admission
Clinically significant abnormal physical or neurological examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission
History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
Subjects with a relevant history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 6 months (a level of 4 or 5), or who are at significant risk to commit suicide, as judged by the investigator using the columbia suicide severity rating score (C-SSRS)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Berlin

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-42847922 in Healthy Male and Female Subjects

Read the detailed description

This is a Phase 1, double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug assigned by chance), placebo controlled, multiple ascending dose study. The study will consist of 3 parts: a Screening period (Days -21 to -2), a Double-blind treatment period (Day -1 to Day 11), and a Follow-up period (within 7 to 14 days after last dose administration). In double blind treatment period, participants will be randomly assigned to 5, 10, 20, and 40 milligram (mg) or placebo. Number of participants with any clinically relevant changes (adverse events [AEs], laboratory results,electrocardiogram [ECG], Vital signs, Physical and neurological, sedation \& concentration) and columbia suicide severity rating (CSSR) scale will be evaluated as primary outcome measure. Participants' safety will be monitored throughout the study.

Conditions: Healthy
Being tested: JNJ-42847922 5 mg, JNJ-42847922 10 mg, JNJ-42847922 20 mg, JNJ-42847922 40 mg, Placebo
Keywords: JNJ-42847922, Phase 1, Healthy, Placebo

What participants receive

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

JNJ-42847922 5 mgDrug
Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.
JNJ-42847922 10 mgDrug
Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.
JNJ-42847922 20 mgDrug
Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.
JNJ-42847922 40 mgDrug
Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .
PlaceboDrug
Participants will receive matching placebo from Day 1 up to Day 10.

Study groups in NCT02230878
Study group	Role	What they receive
JNJ-42847922, 5 milligram (mg) and Placebo	Experimental	Participants will be receive either 5 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10. Receives: Drug: JNJ-42847922 5 mg; Drug: Placebo
JNJ-42847922, 10 mg and Placebo	Experimental	Participants will be receive either 10 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10. Receives: Drug: JNJ-42847922 10 mg; Drug: Placebo
JNJ-42847922, 20 mg and Placebo	Experimental	Participants will be receive either 20 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10. Receives: Drug: JNJ-42847922 20 mg; Drug: Placebo
JNJ-42847922, 40 mg and Placebo	Experimental	Participants will be receive either 40mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10. Receives: Drug: JNJ-42847922 40 mg; Drug: Placebo

What is being measured

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

Supine and Standing Systolic and Diastolic Blood Pressure (BP)
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Supine and Standing Heart Rate
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Tympanic Temperature
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
12 Lead Electrocardiogram (ECG): RR, QRS, PR, QT, QTcB, QTcF Interval
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Number of Participants with Adverse Events
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Number of Participants With Change From Baseline in Laboratory Tests Results
Laboratory values included Hematology, clinical chemistry and urinalysis.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Physical and Neurological Examination
Physical and neurological examination will be performed.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal

Secondary outcomes (17)

Maximum Plasma Concentration (C[max])
The C(max) is the maximum plasma concentration which will be observed at the defined time points.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Time to Reach the Maximum Plasma Concentration (T[max])
The T[max] is time to reach the observed maximum plasma concentration.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Time to Reach Last Quantifiable Plasma Concentration (T[last])
The T[last] is time to reach the observed maximum plasma concentration.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to hour 24 Time (AUC [0-24])
AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])
AUC (last) is the area under the plasma concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Average Plasma Concentration at Steady-State (C[avg])
C(avg) is the average plasma concentration at steady state, calculated as AUC 0-24 divided by 24
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Trough Plasma Concentration (C[trough])
Trough plasma concentration is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Total Clearance (CL/F)
CL/F is the total clearance of drug after extravascular administration, uncorrected for absolute bioavailability. It is calculated as Dose divided by AUC.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Volume of Distribution (Vd/F)
Vd/F is the volume of distribution after extravascular administration, uncorrected for absolute bioavailability.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Elimination Half-life Period (t1/2)
Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z).
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Terminal slope (Lambda [z])
Terminal slope is defined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Mean Residence Time (MRT)
MRT is the mean residence time calculated as area under the first moment curve at infinity (AUMC[0-∞]) divided by AUC[0-∞].
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Amount of Drug Excreted in Urine (Ae)
Ae is the amount of urine excreted in urine. It is calculated by multiplying the urinary volume with the urinary concentration.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Amount of Drug Excreted into Urine During the 24-hour Dosing Interval (Ae[0-24])
Ae(0-24h) is the amount of drug excreted into urine during the 24-hour dosing interval.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Percentage of Drug Excreted in Urine (Ae%dose)
Ae%dose is the percentage of drug excreted into the urine calculated as (Ae divided by dose)∗100.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Renal Clearance (CL[R])
CL(R) is the renal clearance of the drug, calculated as Ae/AUC[0-infinity] on Day 1 or Ae(0-24)/AUC(0-24) on Day 5 and Day 10.
Measured: Baseline up to End of study (7-14 days after last dose) or Early withdrawal

Timeline

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

May 2014Nov 2014

First posted3 Sep 2014 (estimated)
Study startMay 2014
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02230878
Sponsor's protocol ID: CR104154
Other IDs: 42847922EDI1003, 2014-000600-95, 2014
Status last verified: Jan 2017
First submitted: 14 Aug 2014
Last updated: 24 Jan 2017
Results posted: No
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?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-42847922 in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT02230878
Acronym / sponsor ID: CR104154
Conditions: Healthy
Keywords: JNJ-42847922, Phase 1, Healthy, Placebo
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Janssen-Cilag International NVIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 3 Sep 2014 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
JNJ-42847922, 5 milligram (mg) and Placebo	Experimental	Drug: JNJ-42847922 5 mg, Drug: PlaceboParticipants will be receive either 5 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
JNJ-42847922, 10 mg and Placebo	Experimental	Drug: JNJ-42847922 10 mg, Drug: PlaceboParticipants will be receive either 10 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
JNJ-42847922, 20 mg and Placebo	Experimental	Drug: JNJ-42847922 20 mg, Drug: PlaceboParticipants will be receive either 20 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
JNJ-42847922, 40 mg and Placebo	Experimental	Drug: JNJ-42847922 40 mg, Drug: PlaceboParticipants will be receive either 40mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Women should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years
Body Mass Index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive (BMI=weight/height^2)
Participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase
Non-smokers (not smoked for 6 months prior to screening)
Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

Key exclusion criteria (5 listed)

Clinically significant abnormal values for hematology, serum chemistry or urinalysis at screening or admission
Clinically significant abnormal physical or neurological examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission
History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
Subjects with a relevant history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 6 months (a level of 4 or 5), or who are at significant risk to commit suicide, as judged by the investigator using the columbia suicide severity rating score (C-SSRS)

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
JNJ-42847922 5 mgParticipants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.	Drug	JNJ-42847922, 5 milligram (mg) and Placebo
JNJ-42847922 10 mgParticipants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.	Drug	JNJ-42847922, 10 mg and Placebo
JNJ-42847922 20 mgParticipants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.	Drug	JNJ-42847922, 20 mg and Placebo
JNJ-42847922 40 mgParticipants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .	Drug	JNJ-42847922, 40 mg and Placebo
PlaceboParticipants will receive matching placebo from Day 1 up to Day 10.	Drug	JNJ-42847922, 10 mg and Placebo, JNJ-42847922, 20 mg and Placebo, JNJ-42847922, 40 mg and Placebo, JNJ-42847922, 5 milligram (mg) and Placebo

Primary outcome

Supine and Standing Systolic and Diastolic Blood Pressure (BP)
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).
Supine and Standing Heart Rate
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Tympanic Temperature
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
12 Lead Electrocardiogram (ECG): RR, QRS, PR, QT, QTcB, QTcF Interval
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Number of Participants with Adverse Events
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Laboratory values included Hematology, clinical chemistry and urinalysis.
Physical and Neurological Examination
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Physical and neurological examination will be performed.

17 secondary outcomes

Maximum Plasma Concentration (C[max])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Time to Reach the Maximum Plasma Concentration (T[max])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Time to Reach Last Quantifiable Plasma Concentration (T[last])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to hour 24 Time (AUC [0-24])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Average Plasma Concentration at Steady-State (C[avg])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Trough Plasma Concentration (C[trough])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Total Clearance (CL/F)
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Volume of Distribution (Vd/F)
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Elimination Half-life Period (t1/2)
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Terminal slope (Lambda [z])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Mean Residence Time (MRT)
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Amount of Drug Excreted in Urine (Ae)
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Amount of Drug Excreted into Urine During the 24-hour Dosing Interval (Ae[0-24])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Percentage of Drug Excreted in Urine (Ae%dose)
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Renal Clearance (CL[R])
Time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.

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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.

Janssen-Cilag International NV Clinical Trial study director

Janssen-Cilag International NV

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-42847922 5 mg, JNJ-42847922 10 mg and JNJ-42847922 20 mg in people with Healthy, run by Janssen-Cilag International NV at 1 site in Germany.

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 5 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Supine and Standing Systolic and Diastolic Blood Pressure (BP) (time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal). The study lists 8 primary outcomes in all. 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 NCT02230878.

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 24 Jan 2017.