Parkinson DiseasePhase 3NCT01215227
An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)
A Phase 3 study testing Preladenant and Rasagiline in people with Parkinson Disease and Idiopathic Parkinson Disease, run by Merck Sharp & Dohme LLC.
Trial summary
The primary purpose of this extension study is to assess the long-term safety and tolerability of preladenant in participants from parent studies NCT01155466 [P04938] and NCT01227265 [P07037] with moderate to severe Parkinson's Disease (PD). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease, Idiopathic Parkinson Disease
- What is being tested?
- Preladenant and Rasagiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 839 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2010to 16 Jul 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have completed the 12-week treatment period of the parent trial, P04938 or P07037.
- Participants must be willing and able to provide written informed consent for P06153.
- Participants must be able to adhere to dose and visit schedules.
- Participants must be taking L-dopa.
- Participants may be taking additional adjunct PD medications (e.g., dopamine agonists, entacapone).
- Each participant must have results of clinical laboratory tests (hematology, blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator as evidenced by the last available test results from the parent study (P04938 or P07037), and no results fall within the parameters for exclusion described below in the exclusion criterion for liver-related findings.
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- There has been no change in, or there has been no finding to warrant checking, serology status (for cytomegalovirus [CMV], Epstein-Barr virus [EBV], and Hepatitis B, C, and E).
- Each participant must have results of a physical examination within normal limits, including blood pressure, within normal limits or clinically acceptable limits to the investigator, and not within the parameters for exclusion described below in the exclusion criterion for blood pressure.
- All participants who are sexually active or plan to be sexually active agree to use a highly effective method of birth control while the participant is in the study and for 2 weeks after the last dose of study drug. A male participant must not donate sperm within 2 weeks after the last dose of study drug.
Who cannot join
- Any participant who discontinued from P04938 or P07037 for any reason.
- Any participant with a severe or ongoing unstable medical condition (e.g., any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence).
- Any participant with a history of poorly controlled diabetes (e.g., hemoglobin A1c > 8.5) or significantly abnormal renal function (e.g., creatinine > 2.0 mg/dL) in the opinion of the investigator.
- As a continuation of the liver-related withdrawal criteria from the parent studies (P04938 and P07037), any participant with elevated values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (T BIL), as evidenced by the most recent chemistry panel results in the parent study, meeting any one of the following criteria:
- ALT or AST > 8 x upper limit of normal (ULN).
- ALT or AST > 5 x ULN for more than 2 weeks.
Show all 19Show fewer
- ALT or AST > 3 x ULN and (T-BIL > 2 x ULN or international normalized ratio [INR] > 1.5 that is not due to anti-coagulation) at the same visit.
- ALT or AST > 3 x ULN with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%).
- As a continuation of the blood pressure (BP) withdrawal criteria from the parent study (P04938 or P07037), any participant meeting the following criteria for the second of two consecutive visits separated by 7 days (i.e., the participant met one of the BP criteria once already, 7 days before the P06153 screening visit):
- Systolic BP ≥ 180 mm Hg or diastolic BP ≥ 105 mm Hg, or
- An elevation from baseline BP in the parent study (P04938 or P07037) of systolic BP >= 40 mm Hg or diastolic BP ≥ 20 mm Hg.
- A participant must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection.
- Any participant with an average daily consumption of more than three 4-ounce glasses (118 mL) of wine or the equivalent.
- A participant must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (e.g., Stilton) for a prespecified time window before the trial, during the trial, and for 2 weeks after the trial.
- Any participant with allergy/sensitivity to the investigational products or their excipients.
- Any female participant breast feeding or considering breast feeding.
- Any female participant pregnant or intending to become pregnant.
- Any participant with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
- Any participant with a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
About this study
Official title: A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153)
The primary purpose of this extension study is to assess the long-term safety and tolerability of preladenant in participants from parent studies NCT01155466 [P04938] and NCT01227265 [P07037] with moderate to severe Parkinson's Disease (PD). The study will also characterize the long-term efficacy of preladenant in participants with PD.
Participants will continue to receive their stable regimen of levodopa (L-dopa) plus any adjunct medications during the study as prescribed by their physician. Several classes of adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase inhibitors, and dopamine agonists.
- Conditions
- Parkinson Disease, Idiopathic Parkinson Disease
- Being tested
- Preladenant, Rasagiline, Placebo to preladenant, Placebo to rasagiline
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreladenantDrug
Also called SCH 420814
Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose)
RasagilineDrug
Also called Azilect®
Daily for 40 weeks: 1 mg rasagiline capsule each morning
Placebo to preladenantDrug
Placebo to match preladenant given daily for 40 weeks: placebo tablet each morning; placebo tablet each evening (approximately 8 hours after the morning dose)
Placebo to rasagilineDrug
Placebo to match rasagiline given daily for 40 weeks: placebo capsule each morning
| Study group | Role | What they receive |
|---|---|---|
| Preladenant 2 mg | Experimental | Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 2 mg in this extension study. Participants will receive preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Receives: Drug: Preladenant; Drug: Placebo to rasagiline |
| Preladenant 5 mg | Experimental | Participants who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 5 mg in this extension study. Participants will receive preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Receives: Drug: Preladenant; Drug: Placebo to rasagiline |
| Preladenant 5 mg (on placebo in parent study) | Experimental | Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 will receive preladenant 5 mg in this extension study. Participants will receive preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Receives: Drug: Preladenant; Drug: Placebo to rasagiline |
| Preladenant 10 mg | Experimental | Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 10 mg in this extension study. Participants will receive preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Receives: Drug: Preladenant |
| Rasagiline 1 mg | Active comparator | Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 will continue to receive rasagiline 1 mg in this extension study. Participants will receive rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks. Receives: Drug: Rasagiline; Drug: Placebo to preladenant |
| Rasagiline 1 mg (on placebo in parent study) | Active comparator | Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 will receive rasagiline 1 mg in this extension study. Participants will receive rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks. Receives: Drug: Rasagiline; Drug: Placebo to preladenant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Systolic Blood Pressure ≥180 mmHg
The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).
Measured: Up to 42 weeks
Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg
The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).
Measured: Up to 42 weeks
Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline
The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.
Measured: Up to 42 weeks
Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline
The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.
Measured: Up to 42 weeks
Percentage of Participants With Suicidality
The number of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.
Measured: Up to 42 weeks
Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40
The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness.
Measured: Baseline and Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study start18 Nov 2010
- Primary completion16 Jul 2013
- Study completion16 Jul 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 Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215227
- Sponsor's protocol ID
- P06153
- Other IDs
- 2009-015162-57, 2009
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2010
- Last updated
- 6 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153)
- ClinicalTrials.gov ID
- NCT01215227
- Acronym / sponsor ID
- P06153
- Conditions
- Parkinson Disease, Idiopathic Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2010 (actual)
- Primary completion
- 16 Jul 2013 (actual)
- Study completion
- 16 Jul 2013 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this extension study is to assess the long-term safety and tolerability of preladenant in participants from parent studies NCT01155466 [P04938] and NCT01227265 [P07037] with moderate to severe Parkinson's Disease (PD). The study will also characterize the long-term efficacy of preladenant in participants with PD.
Participants will continue to receive their stable regimen of levodopa (L-dopa) plus any adjunct medications during the study as prescribed by their physician. Several classes of adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase inhibitors, and dopamine agonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Preladenant 2 mg | Experimental | Drug: Preladenant, Drug: Placebo to rasagilineParticipants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 2 mg in this extension study. Participants will receive preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. |
| Preladenant 5 mg | Experimental | Drug: Preladenant, Drug: Placebo to rasagilineParticipants who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 5 mg in this extension study. Participants will receive preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. |
| Preladenant 5 mg (on placebo in parent study) | Experimental | Drug: Preladenant, Drug: Placebo to rasagilineParticipants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 will receive preladenant 5 mg in this extension study. Participants will receive preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. |
| Preladenant 10 mg | Experimental | Drug: PreladenantParticipants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 will continue to receive preladenant 10 mg in this extension study. Participants will receive preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. |
| Rasagiline 1 mg | Active comparator | Drug: Rasagiline, Drug: Placebo to preladenantParticipants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 will continue to receive rasagiline 1 mg in this extension study. Participants will receive rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks. |
| Rasagiline 1 mg (on placebo in parent study) | Active comparator | Drug: Rasagiline, Drug: Placebo to preladenantParticipants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 will receive rasagiline 1 mg in this extension study. Participants will receive rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants who have completed the 12-week treatment period of the parent trial, P04938 or P07037.
- Participants must be willing and able to provide written informed consent for P06153.
- Participants must be able to adhere to dose and visit schedules.
- Participants must be taking L-dopa.
- Participants may be taking additional adjunct PD medications (e.g., dopamine agonists, entacapone).
Key exclusion criteria (19 listed)
- Any participant who discontinued from P04938 or P07037 for any reason.
- Any participant with a severe or ongoing unstable medical condition (e.g., any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence).
- Any participant with a history of poorly controlled diabetes (e.g., hemoglobin A1c > 8.5) or significantly abnormal renal function (e.g., creatinine > 2.0 mg/dL) in the opinion of the investigator.
- As a continuation of the liver-related withdrawal criteria from the parent studies (P04938 and P07037), any participant with elevated values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (T BIL), as evidenced by the most recent chemistry panel results in the parent study, meeting any one of the following criteria:
- ALT or AST > 8 x upper limit of normal (ULN).
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 |
|---|---|---|
| PreladenantAlso: SCH 420814Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose) | Drug | Preladenant 10 mg, Preladenant 2 mg, Preladenant 5 mg, Preladenant 5 mg (on placebo in parent study) |
| RasagilineAlso: Azilect®Daily for 40 weeks: 1 mg rasagiline capsule each morning | Drug | Rasagiline 1 mg, Rasagiline 1 mg (on placebo in parent study) |
| Placebo to preladenantPlacebo to match preladenant given daily for 40 weeks: placebo tablet each morning; placebo tablet each evening (approximately 8 hours after the morning dose) | Drug | Rasagiline 1 mg, Rasagiline 1 mg (on placebo in parent study) |
| Placebo to rasagilinePlacebo to match rasagiline given daily for 40 weeks: placebo capsule each morning | Drug | Preladenant 2 mg, Preladenant 5 mg, Preladenant 5 mg (on placebo in parent study) |
Primary outcome
Percentage of Participants With Systolic Blood Pressure ≥180 mmHg
Time frame: Up to 42 weeks
The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).
Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg
Time frame: Up to 42 weeks
The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).
Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline
Time frame: Up to 42 weeks
The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.
Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline
Time frame: Up to 42 weeks
The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.
Percentage of Participants With Suicidality
Time frame: Up to 42 weeks
The number of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.
Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40
Time frame: Baseline and Week 40
The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preladenant and Rasagiline in people with Parkinson Disease and Idiopathic Parkinson Disease, run by Merck Sharp & Dohme LLC.
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 9 inclusion and 19 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: stopped early, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 12 Dec 2016). 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?
Percentage of Participants With Systolic Blood Pressure ≥180 mmHg (time frame: Up to 42 weeks). The study lists 6 primary outcomes in all. 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 6 Nov 2018.