HypertensionPhase 2/3NCT00151775

Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure

A Phase 2/3 study testing olmesartan medoxomil in people with Hypertension, run by Daiichi Sankyo at 65 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks. Read more about this study

Who is it for?: Ages 1 year to 16 years
Conditions the study is for: Hypertension
What is being tested?: olmesartan medoxomil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 362 participants
Where: 65 sitesin 11 countries
Study dates: May 2005to Sep 2008
Phase: Phase 2/3
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 1 year to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

The patient's seated systolic BP (SeSBP) will be greater than or equal to 95th percentile for gender and height-for- age, or greater than or equal to 90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension.
Negative for hepatitis B and C
Negative for HIV

Who cannot join

Patient should not have serious other conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patient in the trial.
Known sensitivity to olmesartan medoxomil
Taking prohibited medication
Consumed greater than 180 mg of caffeine daily
Malignant hypertension
History of congestive heart failure, cardiomyopathy, or obstructive valve disease
Renal transplant within the previous 6 months
Severe nephritic syndrome not in remission

Trial locations and contacts

65 sites in 11 countries.

Country

City, postcode or hospital

65 sites in 11 countries

United States28 sites

Study site
Baltimore, Maryland
Study site
Beaumont, Texas
Study site
Beverly Hills, California
Study site
Birmingham, Alabama
Study site
Charlottesville, Virginia
Study site
Cincinnati, Ohio
Study site
Dayton, Ohio
Study site
Decatur, Georgia
Study site
Fresno, California
Study site
Grand Rapids, Michigan
Study site
Hackensack, New Jersey
Study site
Honolulu, Hawaii
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Kinston, North Carolina
Study site
Las Vegas, Nevada
Study site
Little Rock, Arkansas
Study site
Los Angeles, California, 90049
Study site
Miami, Florida
Study site
New Brunswick, New Jersey
Study site
New Orleans, Louisiana
Study site
Orlando, Florida
Study site
Park Ridge, Illinois
Study site
Phoenix, Arizona, 85013
Study site
Portland, Oregon
Study site
Shreveport, Louisiana
Study site
Tampa, Florida, 33647
Study site
Washington D.C., District of Columbia

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South Africa10 sites

Study site
Bloemfontein, 9300
Study site
Cape Town, 7764
Study site
Durban, KZ-Natal
Study site
E Cape
Study site
Eastern Cape, 5200
Study site
Park Town, Gauteng
Study site
Pietermaritzburg, KZ-Natal
Study site
Potchefstroom, Northwest
Study site
Pretoria, Gauteng
Study site
Western Cape, 7130

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India9 sites

Study site
Ahmedabad, Gujarat
Study site
Chandigarh
Study site
Hyderabad, 500 033
Study site
Lucknow, Uttar Prad
Study site
Mangalore, Karna
Study site
New Delhi, 110 029
Study site
Tamil Nadu
Study site
Trivandrum, Kerala
Study site
Vellore, Karna

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Argentina5 sites

Study site
Bahía Blanca
Study site
Buenos Aires
Study site
Capital Federal
Study site
Mar del Plata
Study site
San Miguel de Tucumán, TUC

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Brazil5 sites

Study site
Campinas
Study site
Curitiba
Study site
Porto Alegre
Study site
Recife
Study site
São Paulo

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Colombia2 sites

Study site
Bogotá
Study site
Cali-Valle

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Zambia2 sites

Study site
Kitwe
Study site
Lusaka

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Chile1 site

Study site
Santiago

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Kenya1 site

Study site
Nairobi

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Peru1 site

Study site
Lima

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Uganda1 site

Study site
Kampala

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About this study

Official title: Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Read the detailed description

This was a randomized, multicenter, double-blind, parallel-group, prospective dose-ranging study in subjects 1 to 16 years of age with hypertension. Subjects were enrolled into 1 of 3 cohorts based on age and race. Subjects 6 to 16 years of age were enrolled into Cohort A. Subjects enrolled into Cohort A were stratified by age with approximately half aged 6 to 12 years and the remainder aged 13 to 16 years. Approximately 15% of the subjects in Cohort A were to be Black or of African descent. When a minimum of 28 Black subjects were randomized into Cohort A, enrollment in Cohort B was started. Black subjects only, 6 to 16 years of age, were enrolled into Cohort B. For Cohorts A and B body weight of any patient was >=20Kg. Seated systolic blood pressure (SeSBP) was >=95th percentile for gender and height-for-age, or >=90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension. Patients with symptomatic hypertension requiring immediate established therapy, or who are above 2 standard deviations (SD) above the 99th percentile did not participate in the study.

Subjects 1 to 5 years of age were enrolled into Cohort C regardless of race. Body weight of any patient was >=5Kg. SeSBP was >=95th percentile for gender and height-for-age, or >=90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension. Patients on stable doses of concomitant antihypertensive agents including calcium channel blockers and/or diuretics only are permitted to enroll. Patients with symptomatic hypertension requiring immediate established therapy, or who are above 2 SD above the 99th percentile did not participate in the study.

The study comprised four periods. Period I was a wash-out period from Week -1 to randomization. Subjects were randomized to treatment sequences carried through the remainder of the study. Period II was a three-week, double-blind, dose-ranging period for Cohorts A and B, beginning at Day 1 and ending at the end of Week 3. In Cohorts A and B, subjects received either low-dose or high-dose olmesartan (OM) once daily. In Cohort C, Period II was an open-label OM treatment period where all subjects received 0.3 mg/kg OM per day. Period III was a double-blind, placebo-controlled withdrawal period beginning at Week 4 and ending after 1 or 2 weeks, depending on the seated blood pressure measurement at each weekly study visit. Subjects either continued their Period II OM regimen or switched to placebo based on the initial randomization scheme. Period IV was a 46-week open-label extension period.

Conditions: Hypertension
Being tested: olmesartan medoxomil, placebo
Keywords: Treatment of hypertension or high blood pressure in children ages 1-16 years.
Medical subject headings: Hypertension

What participants receive

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

olmesartan medoxomilDrug
Also called Benicar (olmesartan medoxomil)
Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension.
Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily
placeboDrug
Cohorts A, B, C: placebo, once daily
olmesartan medoxomilDrug
Also called Benicar (olmesartan medoxomil)
Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly.
Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg

Study groups in NCT00151775
Study group	Role	What they receive
Period 2	Experimental	For Cohorts A and B, olmesartan medoxomil suspension 2.5 mg to 40 mg in patients 6-16 years old, depending on weight. For Cohort C, olmesartan medoxomil suspension 0.3 mg/kg to in patients 1-5 years old. Receives: Drug: olmesartan medoxomil
Period 3	Experimental	Cohorts A, B, C - olmesartan medoxomil suspension or placebo taken once daily. Olmesartan medoxomil dose continued as in previous period. Receives: Drug: olmesartan medoxomil; Drug: placebo
Period 4	Experimental	Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg Receives: Drug: olmesartan medoxomil

What is being measured

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

Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)
The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.
Measured: Day 0 to 3 weeks
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)
Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Measured: Day 0 (baseline) to 3 weeks

Secondary outcomes (4)

Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Measured: Week 3 (period 3 baseline) to week 5 (end of Period 3)
Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.
Measured: Week 3 (period 3 baseline) to week 5 (end of Period 3)
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Measured: Day 0 to week 51 (end of study)
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.
Measured: Day 0 to week 51 week (end of study)

Timeline

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

May 2005Sep 2008

First posted9 Sep 2005 (estimated)
Study startMay 2005
Primary completionSep 2008
Study completionSep 2008

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 HypertensionStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 362 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00151775
Sponsor's protocol ID: CS0866-A-U301
Status last verified: May 2016
First submitted: 7 Sep 2005
Last updated: 30 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

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 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension
ClinicalTrials.gov ID: NCT00151775
Acronym / sponsor ID: CS0866-A-U301
Conditions: Hypertension
Keywords: Treatment of hypertension or high blood pressure in children ages 1-16 years.
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 362 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 9 Sep 2005 (estimated)
Results: Posted 2 Apr 2010

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, investigator)
Number of arms: 3

Arm	Type	Receives
Period 2	Experimental	Drug: olmesartan medoxomilFor Cohorts A and B, olmesartan medoxomil suspension 2.5 mg to 40 mg in patients 6-16 years old, depending on weight. For Cohort C, olmesartan medoxomil suspension 0.3 mg/kg to in patients 1-5 years old.
Period 3	Experimental	Drug: olmesartan medoxomil, Drug: placeboCohorts A, B, C - olmesartan medoxomil suspension or placebo taken once daily. Olmesartan medoxomil dose continued as in previous period.
Period 4	Experimental	Drug: olmesartan medoxomilCohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg

Who may qualify

Ages: 1 year to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

The patient's seated systolic BP (SeSBP) will be greater than or equal to 95th percentile for gender and height-for- age, or greater than or equal to 90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension.
Negative for hepatitis B and C
Negative for HIV

Key exclusion criteria (8 listed)

Patient should not have serious other conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patient in the trial.
Known sensitivity to olmesartan medoxomil
Taking prohibited medication
Consumed greater than 180 mg of caffeine daily
Malignant hypertension

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
olmesartan medoxomilAlso: Benicar (olmesartan medoxomil)Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension. Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily	Drug	Period 2, Period 3
placeboCohorts A, B, C: placebo, once daily	Drug	Period 3
olmesartan medoxomilAlso: Benicar (olmesartan medoxomil)Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly. Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg	Drug	Period 4

Primary outcome

Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)
Time frame: Day 0 to 3 weeks
The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)
Time frame: Day 0 (baseline) to 3 weeks
Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.

4 secondary outcomes

Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Time frame: Week 3 (period 3 baseline) to week 5 (end of Period 3)
Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Time frame: Week 3 (period 3 baseline) to week 5 (end of Period 3)
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Time frame: Day 0 to week 51 (end of study)
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Time frame: Day 0 to week 51 week (end of study)

Results and safety

Results posted to the registry on 2 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: High Dose OM in Periods 2, 3	95	93
Cohort A: Low Dose OM in Periods 2, 3	95	89
Cohort A: Placebo in Period 3 (From High Dose in Period 2)	0	0
Cohort A: Placebo in Period 3 (From Low Dose in Period 2)	0	0
Cohort A: Period 4 Open-label OM	0	0
Cohort B: High Dose OM in Periods 2, 3	56	54
Cohort B: Low Dose OM in Periods 2, 3	56	53
Cohort B: Placebo in Period 3 (From High Dose in Period 2)	0	0
Cohort B: Placebo in Period 3 (From Low Dose in Period 2)	0	0
Cohort B: Period 4 Open-label OM	0	0
Cohort C: OM in Periods 2, 3, 4	60	59
Cohort C: Placebo in Period 3 (From OM in Period 2)	0	0

Primary outcome: Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)

Time frame: Day 0 to 3 weeks. Least squares mean (Standard Error). Unit: mm Hg

Measure	Cohort A n = 190	Cohort B n = 112	Cohorts A + B n = 302
Non-weight adjusted dosage	-0.69 (0.202)	-0.85 (0.282)	-0.75 (0.165)
Weight adjusted dosage	-8.97 (2.054)	-7.17 (3.190)	-8.36 (1.750)

Cohort A: p = 0.0008, Regression, Linear
Cohort A: p <0.0001, Regression, Linear
Cohort B: p = 0.0032, Regression, Linear

Population analysed: The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.

Primary outcome: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)

Time frame: Day 0 (baseline) to 3 weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Cohort A: Low Dose OM n = 94	Cohort A: High Dose OM n = 94	Cohort B: Low Dose OM n = 56	Cohort B: High Dose OM n = 56	Cohorts A + B: Low Dose OM n = 150	Cohorts A + B: High Dose OM n = 150
Change in Systolic Blood Pressure	-7.76 (9.180)	-12.58 (10.157)	-4.73 (11.483)	-10.68 (9.259)	-6.63 (10.170)	-11.87 (9.843)
Change in Diastolic Blood Pressure	-5.52 (8.058)	-9.50 (9.757)	-3.49 (8.844)	-7.58 (8.172)	-4.76 (8.389)	-8.78 (9.216)

Cohort A: Low Dose OM vs Cohort A: High Dose OM: Slope: 0.69, p = 0.0008, Regression, Linear
Cohort A: Low Dose OM vs Cohort A: High Dose OM: Slope: -.057, p = 0.0026, Regression, Linear
Cohort B: Low Dose OM vs Cohort B: High Dose OM: Slope: -0.85, p = 0.0032, Regression, Linear

Population analysed: The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks). Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: Period 2 High Dose OM	2 of 95 (2.1%)	47 of 95 (49.5%)	Not reported
Cohort A: Period 2 Low Dose OM	1 of 95 (1.1%)	46 of 95 (48.4%)	Not reported
Cohort A: Period 3 OM High Dose Continued	0 of 48 (0%)	15 of 48 (31.3%)	Not reported
Cohort A: Period 3 Placebo From High Dose	0 of 45 (0%)	6 of 45 (13.3%)	Not reported
Cohort A: Period 3 OM Low Dose Continued	0 of 45 (0%)	9 of 45 (20%)	Not reported
Cohort A: Period 3 Placebo From Low Dose	0 of 44 (0%)	6 of 44 (13.6%)	Not reported
Cohort A: Period 4 Open-label OM	20 of 179 (11.2%)	128 of 178 (71.9%)	Not reported
Cohort B: Period 2 High Dose OM	0 of 56 (0%)	9 of 56 (16.1%)	Not reported
Cohort B: Period 2 Low Dose OM	0 of 56 (0%)	12 of 56 (21.4%)	Not reported
Cohort B: Period 3 OM High Dose Continued	1 of 26 (3.8%)	4 of 26 (15.4%)	Not reported
Cohort B: Period 3 Placebo From High Dose	0 of 28 (0%)	1 of 28 (3.6%)	Not reported
Cohort B: Period 3 OM Low Dose Continued	0 of 27 (0%)	2 of 27 (7.4%)	Not reported
Cohort B: Period 3 Placebo From Low Dose	0 of 26 (0%)	1 of 26 (3.8%)	Not reported
Cohort B: Period 4 Open-label OM	7 of 104 (6.7%)	56 of 103 (54.4%)	Not reported
Cohort C: Period 2 Open-label OM	0 of 59 (0%)	12 of 59 (20.3%)	Not reported
Cohort C: Period 3 OM Dose Continued	0 of 29 (0%)	4 of 29 (13.8%)	Not reported
Cohort C: Period 3 Placebo

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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.

65 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing olmesartan medoxomil in people with Hypertension, run by Daiichi Sankyo at 65 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, South Africa, India, Argentina, Brazil and 6 more countries. 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 combined 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.

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 2 Apr 2010). 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?

Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks) (time frame: Day 0 to 3 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?

On the ClinicalTrials.gov record for NCT00151775.

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 30 Jun 2016.