Resistant HypertensionPhase 2NCT00272961

A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.

A Phase 2 study testing TBC3711 in people with Resistant Hypertension, run by Pfizer at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Resistant Hypertension
What is being tested?: TBC3711
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 12 sitesUnited States
Study dates: Jan 2006to Aug 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of resistant hypertension.
A stable anti-hypertensive drug regimen for at least 30 days.

Who cannot join

Sustained blood pressure greater than or equal to 180/120 mmHg.
Required use of thigh cuff for blood pressure readings.
Uncontrolled diabetes mellitus.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Pfizer Investigational Site
Albany, New York, 12206
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Augusta, Georgia, 30904
Pfizer Investigational Site
Birmingham, Alabama, 35294-2041
Pfizer Investigational Site
Carroltown, Texas, 75006
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Germantown, Tennessee, 38138
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73132-4904
Pfizer Investigational Site
Seattle, Washington, 98133
Pfizer Investigational Site
Shreveport, Louisiana, 71101
Pfizer Investigational Site
Simpsonville, South Carolina, 29681

Other trials in United States

About this study

Official title: A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension

The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.

Read the detailed description

The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.

Conditions: Resistant Hypertension
Being tested: Placebo, TBC3711

What participants receive

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

PlaceboDrug
placebo tablet once daily for 12 weeks
TBC3711Drug
10 mg tablets once daily for 10 weeks
TBC3711Drug
50 mg tablet once daily for 10 weeks
TBC3711Drug
100 mg tablet once daily for 10 weeks
TBC3711Drug
200 mg tablet once daily for 10 weeks

Study groups in NCT00272961
Study group	Role	What they receive
placebo	Placebo comparator	Not described Receives: Drug: Placebo
ARM 1	Experimental	Not described Receives: Drug: TBC3711
ARM 2	Experimental	Not described Receives: Drug: TBC3711
ARM 3	Experimental	Not described Receives: Drug: TBC3711
ARM 4	Experimental	Not described Receives: Drug: TBC3711

What is being measured

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

Maximum Blood Pressure (BP) Increase
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). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.
Measured: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change
AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.
Measured: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12

Secondary outcomes (8)

Sitting Systolic Blood Pressure (SBP)
SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.
Measured: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Standing Systolic Blood Pressure (SBP)
SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.
Measured: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Sitting Diastolic Blood Pressure (DBP)
DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.
Measured: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Standing Diastolic Blood Pressure (DBP)
DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.
Measured: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10
SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
Measured: Pre-Dose and 2 hours Post-Dose on Week 10
Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10
DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
Measured: Pre-Dose and 2 hours Post-Dose on Week 10
Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10
SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
Measured: Pre-Dose and 2 hours Post-Dose on Week 10
Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10
DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
Measured: Pre-Dose and 2 hours Post-Dose on Week 10

Timeline

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

Jan 2006Aug 2008

First posted9 Jan 2006 (estimated)
Study startJan 2006
Primary completionAug 2008
Study completionAug 2008

Why it stopped: See termination reason in detailed description.

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 Resistant HypertensionStudies of the same condition, open and under way.
More trials run by PfizerThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00272961
Sponsor's protocol ID: B1341001
Other IDs: GRH01
Status last verified: Jan 2013
First submitted: 4 Jan 2006
Last updated: 5 Mar 2013
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

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease

All Resistant Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension
ClinicalTrials.gov ID: NCT00272961
Acronym / sponsor ID: B1341001
Conditions: Resistant Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 60 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 9 Jan 2006 (estimated)
Results: Posted 5 Mar 2013

Clinical summary

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

The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
placebo	Placebo comparator	Drug: Placebo
ARM 1	Experimental	Drug: TBC3711
ARM 2	Experimental	Drug: TBC3711
ARM 3	Experimental	Drug: TBC3711
ARM 4	Experimental	Drug: TBC3711

Who may qualify

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

Key inclusion criteria (2 listed)

Diagnosis of resistant hypertension.
A stable anti-hypertensive drug regimen for at least 30 days.

Key exclusion criteria (3 listed)

Sustained blood pressure greater than or equal to 180/120 mmHg.
Required use of thigh cuff for blood pressure readings.
Uncontrolled diabetes mellitus.

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
Placeboplacebo tablet once daily for 12 weeks	Drug	placebo
TBC371110 mg tablets once daily for 10 weeks	Drug	ARM 1
TBC371150 mg tablet once daily for 10 weeks	Drug	ARM 2
TBC3711100 mg tablet once daily for 10 weeks	Drug	ARM 3
TBC3711200 mg tablet once daily for 10 weeks	Drug	ARM 4

Primary outcome

Maximum Blood Pressure (BP) Increase
Time frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
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). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.
Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change
Time frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.

8 secondary outcomes

Sitting Systolic Blood Pressure (SBP)
Time frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Standing Systolic Blood Pressure (SBP)
Time frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Sitting Diastolic Blood Pressure (DBP)
Time frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Standing Diastolic Blood Pressure (DBP)
Time frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10
Time frame: Pre-Dose and 2 hours Post-Dose on Week 10
Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10
Time frame: Pre-Dose and 2 hours Post-Dose on Week 10
Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10
Time frame: Pre-Dose and 2 hours Post-Dose on Week 10
Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10
Time frame: Pre-Dose and 2 hours Post-Dose on Week 10

Results and safety

Results posted to the registry on 5 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	60	49
TBC3711 10 mg	0	0
TBC3711 50 mg	0	0
TBC3711 100 mg	0	0
TBC3711 200 mg	0	0

Primary outcome: Maximum Blood Pressure (BP) Increase

Time frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12. Least squares mean (Standard Error). Unit: millimeter of mercury (mmHg)

Measure	Placebo n = 10	TBC3711 10 mg n = 8	TBC3711 50 mg n = 11	TBC3711 100 mg n = 10	TBC3711 200 mg n = 10
Sitting SBP (n= 8, 6, 9, 8, 8)	11.48 (4.04)	3.10 (4.67)	11.26 (3.83)	11.52 (4.03)	10.46 (4.09)
Standing SBP (n= 10, 8, 11, 10, 10)	9.06 (3.24)	2.96 (3.64)	8.38 (3.08)	9.63 (3.23)	14.76 (3.23)
Sitting DBP (n= 8, 6, 9, 8, 8)	8.16 (1.75)	2.53 (2.02)	6.73 (1.65)	1.79 (1.77)	7.17 (1.81)
Standing DBP (n= 10, 8, 11, 10, 10)	7.91 (1.69)	3.11 (1.90)	7.11 (1.62)	2.27 (1.69)	6.25 (1.74)

Placebo vs TBC3711 10 mg: Least Squares (LS) Mean Difference: 8.37 (95% CI -4.21 to 20.96), p = 0.185, ANCOVA
Placebo vs TBC3711 50 mg: LS Mean Difference: 0.21 (95% CI -11.16 to 11.59), p = 0.970, ANCOVA
Placebo vs TBC3711 100 mg: LS Mean Difference: -0.04 (95% CI -11.66 to 11.57), p = 0.994, ANCOVA

Population analysed: Safety analysis set included all participants who received at least 1 dose of study treatment. Here "n" signifies participants evaluable for specified category for each treatment arm, respectively.

Primary outcome: Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change

Time frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12. Least squares mean (Standard Error). Unit: mmHg

Measure	Placebo n = 10	TBC3711 10 mg n = 7	TBC3711 50 mg n = 11	TBC3711 100 mg n = 10	TBC3711 200 mg n = 10
Sitting SBP (n= 8, 5, 9, 8, 8)	318.50 (125.20)	85.91 (158.59)	214.83 (119.85)	277.24 (125.27)	152.10 (126.57)
Standing SBP (n= 10, 7, 11, 10, 10)	237.83 (83.52)	74.79 (99.66)	122.48 (79.95)	213.16 (83.46)	187.24 (83.37)
Sitting DBP (n= 8, 5, 9, 8, 8)	256.38 (67.58)	30.82 (85.41)	141.61 (63.97)	31.50 (68.88)	123.17 (70.03)
Standing DBP (n= 10, 7, 11, 10, 10)	282.89 (73.31)	42.26 (87.57)	124.90 (70.65)	27.99 (73.46)	125.23 (75.08)

Placebo vs TBC3711 10 mg: LS Mean Difference: 232.59 (95% CI -178.5 to 643.7), p = 0.2577, ANCOVA
Placebo vs TBC3711 50 mg: LS Mean Difference: 103.67 (95% CI -250.5 to 457.8), p = 0.5552, ANCOVA
Placebo vs TBC3711 100 mg: LS Mean Difference: 41.26 (95% CI -319.8 to 402.3), p = 0.8174, ANCOVA

Population analysed: Safety analysis set: all participants who received at least 1 dose of study treatment. "N"(number of participants analyzed): participants evaluable for this measure and n: participants with non-missing baseline and at least 2 non-missing values in treatment phase or in follow-up for specified category for each treatment arm, respectively.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 10 (0%)	4 of 10 (40%)	Not reported
TBC3711 10 mg	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
TBC3711 50 mg	1 of 11 (9.1%)	3 of 11 (27.3%)	Not reported
TBC3711 100 mg	1 of 10 (10%)	4 of 10 (40%)	Not reported
TBC3711 200 mg	0 of 10 (0%)	5 of 10 (50%)	Not reported

Limitations and caveats (from the sponsor): Results for 'change from standing to sitting SBP and DBP' and 'change from pre-dose to post-dose SBP and DBP' are reported only at Week 10 as per changes in planned analysis because of early termination of the study and clinical development program.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Resistant Hypertension

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease

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.

Pfizer CT.gov Call Center study director

Pfizer

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TBC3711 in people with Resistant Hypertension, run by Pfizer at 12 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 2 inclusion and 3 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 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2013). 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?

Maximum Blood Pressure (BP) Increase (time frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12). 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?

On the ClinicalTrials.gov record for NCT00272961.

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 5 Mar 2013.