High Blood PressurePhase 4NCT03115853
The Effects of Renin Inhibition on Fibrinolytic Balance and Endothelial Function
A Phase 4 study testing Aliskiren 150 mg, HCTZ and Aliskiren 300 mg in people with High Blood Pressure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Aliskiren (also called TekturnaTM) is a new drug for high blood pressure. Aliskiren works by blocking the actions of a substance called renin. Renin is a natural substance in the body that raises blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Aliskiren 150 mg, HCTZ and Aliskiren 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 2012
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-65 with hypertension
- Hypertension is defined as a systolic blood pressure at screening of ≥ 140, a diastolic blood pressure of ≥ 90, or a preexisting diagnosis of hypertension taking antihypertensive medication. If the subject is on anti-hypertensive medication, they can be included in the study, independent of the screening blood pressure.
Who cannot join
- Serum potassium > 5.0 mmol/L (at the visit directly preceding Randomization)
- History of any cardiovascular event (stroke, TIA, MI, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1 or subsequent to enrollment.
- Malignant Hypertension (at Randomization): any patient with SBP > 170 mmHg or DBP > 120 mmHg
- Congestive heart failure NYHA class III and IV
- Unstable serum creatinine
- Second (II) or third (III) degree heart block without a pacemaker.
Show all 26Show fewer
- Concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia.
- Clinically significant valvular heart disease.
- Known renal artery stenosis.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (patients with previous bariatric surgery > 6 months prior to Visit 1 are allowed to participate).
- Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
- Evidence of hepatic disease as determined by any one of the following: SGPT value exceeding 3 x Upper Limit of Normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
- History of malignancy other than basal cell skin cancer within the past five years.
- Any concurrent life threatening condition with a life expectancy less than 2 years.
- History or evidence of drug or alcohol abuse within the last 12 months.
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.
- Persons directly involved in the execution of this protocol.
- Pregnant or nursing (lactating) women
- Transmeridian travel in the past 6 months
- Screening physical and lab findings consistent with the AHA/ADA metabolic syndrome criteria (3 of the following: BP ≥ 130/85 or on antihypertensive medications, waist size > 40" (m) > 35" (f), Fasting Glucose ≥ 100 mg/dl, Triglycerides ≥ 150 mg/dl, HDL <40 mg/dl (m) <50 mg/dl (f))
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Aliskiren (also called TekturnaTM) is a new drug for high blood pressure. Aliskiren works by blocking the actions of a substance called renin. Renin is a natural substance in the body that raises blood pressure. Renin is believed to contribute to the production of blood clots by increasing the amount of a substance known as Plasminogen Activator Inhibitor or PAI-1. This study will measure how aliskiren changes the amount of PAI-1 in the blood depending on the time of dosing. The purpose of this study is to find out if it is better to take aliskiren in the morning or at night.
Read the detailed description
Qualifying subjects will be withdrawn from RAAS blockers in a stepwise fashion over one to two weeks. All other blood pressure medications will be continued. If the subject's blood pressure rises above SBP > 170 or DBP > 120 at any time during the study, they will be excluded and the subject will restart their home medication(s).
Week Two - Visit 2 - Post-taper visit: will be issued hydrochlorothiazide (25mg po, qd x 18 weeks, open label). All study medications will be taken daily between 7 and 10 AM. PAI-1 blood sample will be drawn. Pre-menopausal women will schedule this visit for when they have began their cycle.
Week Four- Visit 3 - If their BP (> 120/60 mmHg), potassium (≤ 5.5 meq/dl) and renal function permit (Cr ≤ 1.5 mg/dl), they will be randomized to aliskiren (150 mg po, qd x 2 weeks) or placebo. If applicable, a urine pregnancy test will be done for child bearing age females.
Week Six - Visit 4 - Titration visit: Subjects will return to the GCRC for an interval history, pill count, blood pressure check, and basic metabolic panel. If their BP, potassium and renal function permit, the medication will be increased to aliskiren (300 mg po, qd x 4 weeks) or placebo (double dose). If applicable, a urine pregnancy test will be done for child bearing age females.
Week Eight - Visit 5 - Post-Titration visit: Subjects will return to the GCRC for an interval history, pill count, blood pressure check and basic metabolic panel. If their BP, potassium and renal function permit, they will remain on the current dose of aliskiren.
Week 10 - Visit 6 - Study Day 1 - Patients will be admitted to the GCRC as an inpatient. They will be asked to lie supine for 24 hours with the head of their bed no higher than 10 degrees. They will have an interval history and physical. An IV catheter will be placed. After an initial void, they will begin a 24 hour urine creatinine, sodium and aldosterone. They will have a baseline BMP, high sensitivity C-Reactive Protein (hsCRP) and CBC. They will have blood drawn every 3 hours for PAI-1 antigen levels, plasma renin activity, plasma ACE activity, plasma aldosterone levels, plasma cortisol and melatonin. White blood cells will be harvested in PaxGene tubes for future extraction of white blood cell mRNA. They will be on a eucaloric, low sodium diet. At the end of the study day they will remain on their home medications, HCTZ (25mg po, qd), however they will stop their current blinded study medication (aliskiren or placebo). Subjects will have DNA banked from unused blood buffy coats. If applicable, UA pregnancy test will be performed by CRC nurses on admission.
Washout Period - The reason for the washout period is four-fold. The washout period insures that drug is completely washed out of the system before initiation of placebo in the arm that received aliskiren first. This will allow the study to observe a placebo effect on blood pressure in the "aliskiren first" arm, in the event that there is one. It would also insure that that sufficient time has passed between SD1 and SD 2 to see the effect of placebo on hsCRP in the "aliskerin first" arm. From a safety standpoint, it insures that subjects have more than 8 weeks to recover their blood counts between study days, as a significant amount of blood is drawn on each study day. Fourth, as there is a menstrual variation in Pai-1 levels, it insures that pre-menopausal women participating in the study will be the same phase of their cycle on SD1 and SD2.
Week 12 - Visit 7 - Mid-Washout visit: Subjects will return to the GCRC for an interval history, pill count, blood pressure check. If their BP permits (<170/120 mmHg) they will remain off study medication. If they are anemic (Hgb < 11) they will be started on iron supplementation.
Week 16 - Visit 8 - Post-Washout visit: Subjects will return to the GCRC for an interval history, pill count, blood pressure check, BMP and CBC, if indicated. If BP and renal function permit, the patient will receive their crossover medication (placebo x 2 weeks or aliskiren 150mg po, qd x 2 weeks). If applicable, a urine pregnancy test will be done for child bearing age females.
Week 18 - Visit 9 - Titration visit 2: Subjects will return to the GCRC for an interval history, pill count, blood pressure check, and basic metabolic panel, and CBC if indicated. If their BP, potassium and renal function permit, the medication will be increased to aliskiren (300 mg po, qd x 4 weeks) or placebo (double dose).
Week 20 - Visit 10 - Post-Titration visit 2: Subjects will return to the GCRC for an interval history, pill count, blood pressure check and basic metabolic pane, and CBC if indicated. If their BP, potassium and renal function permit, they will remain on the current dose of aliskiren. If their Hgb ≥ 11 mg/dl, they will be able to participate in the final study day.
Week 22 - Visit 11 - Study Day 2: Patients will be admitted to the GCRC as an inpatient. They will be asked to lie supine for 24 hours with the head of their bed no higher than 10 degrees. They will have an interval history and physical. An IV catheter will be placed. After an initial void, they will begin a 24 hour urine creatinine, sodium and aldosterone. They will have a baseline BMP, hsCRP, and CBC. They will have blood drawn every 3 hours for PAI-1 antigen levels, plasma renin activity, plasma ACE activity, plasma aldosterone levels, plasma cortisol and melatonin. White blood cells will be harvested in PaxGene tubes for future extraction of white blood cell mRNA. They will be on a eucaloric, low sodium diet. At the end of the study day they will remain on their home medications, and resume home medications that were previously stopped for study purposes. If applicable, UA pregnancy test will be performed by CRC nurses on admission.
- Conditions
- High Blood Pressure
- Being tested
- Aliskiren 150 mg, Placebo, HCTZ, Aliskiren 300 mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren 150 mgDrug
Also called Tekturna
Aliskiren 150 mg daily for 2 weeks
PlaceboDrug
Placebo tablet for Aliskerin
HCTZDrug
HCTZ 25mg every day for 18 weeks
Aliskiren 300 mgDrug
Aliskiren 300 mg for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| HCTZ plus Aliskiren then HCTZ and Placebo | Experimental | HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
Then HCTZ 25 mg po plus Placebo Receives: Drug: Aliskiren 150 mg; Drug: Placebo; Drug: HCTZ; Drug: Aliskiren 300 mg |
| HCTZ and Placebo, then HCTZ and Aliskiren | Experimental | HCTZ 25 mg po plus Placebo.
Then HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated. Receives: Drug: Aliskiren 150 mg; Drug: Placebo; Drug: HCTZ; Drug: Aliskiren 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Peak Plasma PAI-1 Level
Measured: baseline to 18 weeks
Difference in Mean Plasma PAI-1 Level
Measured: baseline to 18 weeks
Secondary outcomes (3)
Difference in Mean Plasma Aldosterone Levels
Measured: baseline to 18 weeks
Difference in Mean Changes in Plasma Renin Activity.
Measured: baseline to 18 weeks
Difference in Mean Plasma Peak Aldosterone Levels
Measured: baseline to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startJun 2009
- Primary completionJan 2012
- Study completionJan 2012
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 High Blood PressureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Muldowney, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115853
- Sponsor's protocol ID
- 090738
- Status last verified
- Jul 2017
- First submitted
- 16 Mar 2017
- Last updated
- 25 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Renin Inhibition on Fibrinolytic Balance and Endothelial Function
- ClinicalTrials.gov ID
- NCT03115853
- Acronym / sponsor ID
- 090738
- Conditions
- High Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Posted 25 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aliskiren (also called TekturnaTM) is a new drug for high blood pressure. Aliskiren works by blocking the actions of a substance called renin. Renin is a natural substance in the body that raises blood pressure. Renin is believed to contribute to the production of blood clots by increasing the amount of a substance known as Plasminogen Activator Inhibitor or PAI-1. This study will measure how aliskiren changes the amount of PAI-1 in the blood depending on the time of dosing. The purpose of this study is to find out if it is better to take aliskiren in the morning or at night.
Detailed description
Qualifying subjects will be withdrawn from RAAS blockers in a stepwise fashion over one to two weeks. All other blood pressure medications will be continued. If the subject's blood pressure rises above SBP > 170 or DBP > 120 at any time during the study, they will be excluded and the subject will restart their home medication(s).
Week Two - Visit 2 - Post-taper visit: will be issued hydrochlorothiazide (25mg po, qd x 18 weeks, open label). All study medications will be taken daily between 7 and 10 AM. PAI-1 blood sample will be drawn. Pre-menopausal women will schedule this visit for when they have began their cycle.
Week Four- Visit 3 - If their BP (> 120/60 mmHg), potassium (≤ 5.5 meq/dl) and renal function permit (Cr ≤ 1.5 mg/dl), they will be randomized to aliskiren (150 mg po, qd x 2 weeks) or placebo. If applicable, a urine pregnancy test will be done for child bearing age females.
Week Six - Visit 4 - Titration visit: Subjects will return to the GCRC for an interval history, pill count, blood pressure check, and basic metabolic panel. If their BP, potassium and renal function permit, the medication will be increased to aliskiren (300 mg po, qd x 4 weeks) or placebo (double dose). If applicable, a urine pregnancy test will be done for child bearing age females.
Week Eight - Visit 5 - Post-Titration visit: Subjects will return to the GCRC for an interval history, pill count, blood pressure check and basic metabolic panel. If their BP, potassium and renal function permit, they will remain on the current dose of aliskiren.
Week 10 - Visit 6 - Study Day 1 - Patients will be admitted to the GCRC as an inpatient. They will be asked to lie supine for 24 hours with the head of their bed no higher than 10 degrees. They will have an interval history and physical. An IV catheter will be placed. After an initial void, they will begin a 24 hour urine creatinine, sodium and aldosterone. They will have a baseline BMP, high sensitivity C-Reactive Protein (hsCRP) and CBC. They will have blood drawn every 3 hours for PAI-1 antigen levels, plasma renin activity, plasma ACE activity, plasma aldosterone levels, plasma cortisol and melatonin. White blood cells will be harvested in PaxGene tubes for future extraction of white blood cell mRNA. They will be on a eucaloric, low sodium diet. At the end of the study day they will remain on their home medications, HCTZ (25mg po, qd), however they will stop their current blinded study medication (aliskiren or placebo). Subjects will have DNA banked from unused blood buffy coats. If applicable, UA pregnancy test will be performed by CRC nurses on admission.
Washout Period - The reason for the washout period is four-fold. The washout period insures that drug is completely washed out of the system before initiation of placebo in the arm that received aliskiren first. This will allow the study to observe a placebo effect on blood pressure in the "aliskiren first" arm, in the event that there is one. It would also insure that that sufficient time has passed between SD1 and SD 2 to see the effect of placebo on hsCRP in the "aliskerin first" arm. From a safety standpoint, it insures that subjects have more than 8 weeks to recover their blood counts between study days, as a significant amount of blood is drawn on each study day. Fourth, as there is a menstrual variation in Pai-1 levels, it insures that pre-menopausal women participating in the study will be the same phase of their cycle on SD1 and SD2.
Week 12 - Visit 7 - Mid-Washout visit: Subjects will return to the GCRC for an interval history, pill count, blood pressure check. If their BP permits (<170/120 mmHg) they will remain off study medication. If they are anemic (Hgb < 11) they will be started on iron supplementation.
Week 16 - Visit 8 - Post-Washout visit: Subjects will return to the GCRC for an interval history, pill count, blood pressure check, BMP and CBC, if indicated. If BP and renal function permit, the patient will receive their crossover medication (placebo x 2 weeks or aliskiren 150mg po, qd x 2 weeks). If applicable, a urine pregnancy test will be done for child bearing age females.
Week 18 - Visit 9 - Titration visit 2: Subjects will return to the GCRC for an interval history, pill count, blood pressure check, and basic metabolic panel, and CBC if indicated. If their BP, potassium and renal function permit, the medication will be increased to aliskiren (300 mg po, qd x 4 weeks) or placebo (double dose).
Week 20 - Visit 10 - Post-Titration visit 2: Subjects will return to the GCRC for an interval history, pill count, blood pressure check and basic metabolic pane, and CBC if indicated. If their BP, potassium and renal function permit, they will remain on the current dose of aliskiren. If their Hgb ≥ 11 mg/dl, they will be able to participate in the final study day.
Week 22 - Visit 11 - Study Day 2: Patients will be admitted to the GCRC as an inpatient. They will be asked to lie supine for 24 hours with the head of their bed no higher than 10 degrees. They will have an interval history and physical. An IV catheter will be placed. After an initial void, they will begin a 24 hour urine creatinine, sodium and aldosterone. They will have a baseline BMP, hsCRP, and CBC. They will have blood drawn every 3 hours for PAI-1 antigen levels, plasma renin activity, plasma ACE activity, plasma aldosterone levels, plasma cortisol and melatonin. White blood cells will be harvested in PaxGene tubes for future extraction of white blood cell mRNA. They will be on a eucaloric, low sodium diet. At the end of the study day they will remain on their home medications, and resume home medications that were previously stopped for study purposes. If applicable, UA pregnancy test will be performed by CRC nurses on admission.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCTZ plus Aliskiren then HCTZ and Placebo | Experimental | Drug: Aliskiren 150 mg, Drug: Placebo, Drug: HCTZ, Drug: Aliskiren 300 mgHCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated. Then HCTZ 25 mg po plus Placebo |
| HCTZ and Placebo, then HCTZ and Aliskiren | Experimental | Drug: Aliskiren 150 mg, Drug: Placebo, Drug: HCTZ, Drug: Aliskiren 300 mgHCTZ 25 mg po plus Placebo. Then HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18-65 with hypertension
Key exclusion criteria (26 listed)
- Serum potassium > 5.0 mmol/L (at the visit directly preceding Randomization)
- History of any cardiovascular event (stroke, TIA, MI, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1 or subsequent to enrollment.
- Malignant Hypertension (at Randomization): any patient with SBP > 170 mmHg or DBP > 120 mmHg
- Congestive heart failure NYHA class III and IV
- Unstable serum creatinine
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 |
|---|---|---|
| Aliskiren 150 mgAlso: TekturnaAliskiren 150 mg daily for 2 weeks | Drug | HCTZ and Placebo, then HCTZ and Aliskiren, HCTZ plus Aliskiren then HCTZ and Placebo |
| PlaceboPlacebo tablet for Aliskerin | Drug | HCTZ and Placebo, then HCTZ and Aliskiren, HCTZ plus Aliskiren then HCTZ and Placebo |
| HCTZHCTZ 25mg every day for 18 weeks | Drug | HCTZ and Placebo, then HCTZ and Aliskiren, HCTZ plus Aliskiren then HCTZ and Placebo |
| Aliskiren 300 mgAliskiren 300 mg for 4 weeks | Drug | HCTZ and Placebo, then HCTZ and Aliskiren, HCTZ plus Aliskiren then HCTZ and Placebo |
Primary outcome
Difference in Peak Plasma PAI-1 Level
Time frame: baseline to 18 weeks
Difference in Mean Plasma PAI-1 Level
Time frame: baseline to 18 weeks
3 secondary outcomes
Difference in Mean Plasma Aldosterone Levels
Time frame: baseline to 18 weeks
Difference in Mean Changes in Plasma Renin Activity.
Time frame: baseline to 18 weeks
Difference in Mean Plasma Peak Aldosterone Levels
Time frame: baseline to 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren 150 mg, HCTZ and Aliskiren 300 mg in people with High Blood Pressure, run by Vanderbilt University Medical Center at 1 site 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 2 inclusion and 26 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 25 Aug 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2017). 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?
Difference in Peak Plasma PAI-1 Level (time frame: baseline to 18 weeks). The study lists 2 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 25 Aug 2017.