HypertensionPhase 3NCT00553267

Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

A Phase 3 study testing fixed dose combination of telmisartan+amlodipine and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 97 sites in 14 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

The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: fixed dose combination of telmisartan+amlodipine and amlodipine
How many people: 947 participants
Where: 97 sitesin 14 countries
Study dates: Nov 2007to Oct 2008
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg if treatment-naïve).
failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP >= 90 mmHg.)
able to stop any current antihypertensive therapy without unacceptable risk to the patient.
willing and able to provide written informed consent.

Who cannot join

pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
known or suspected secondary hypertension.
mean seated systolic blood pressure (SBP) >=200 mmHg and/or mean seated DBP >= 120 mmHg during run-in treatment or mean seated SBP >= 180 mmHg and/or mean seated DBP >= 120 mmHg at the randomisation visit or at any time during randomised treatment.
any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
clinically relevant hyperkalaemia.
uncorrected volume or sodium depletion.

Show all 18Show fewer

primary aldosteronism.
hereditary fructose or lactose intolerance.
symptomatic congestive heart failure.
patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARBs.
history of drug or alcohol dependency within the six months prior to signing consent.
concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent.
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
known allergic hypersensitivity to any component of the formulations under investigation. (Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine CCBs.)
non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period.
current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period.
chronic administration of any medication known to affect blood pressure, other than the trial medication.
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.

Trial locations and contacts

97 sites in 14 countries.

Country

City, postcode or hospital

97 sites in 14 countries

United Kingdom16 sites

1235.6.44010 Boehringer Ingelheim Investigational Site
Bexhill-on-Sea
1235.6.44008 Boehringer Ingelheim Investigational Site
Blackpool
1235.6.44016 Boehringer Ingelheim Investigational Site
Blackpool
1235.6.44011 Boehringer Ingelheim Investigational Site
Burbage, Hinkley
1235.6.44007 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable
1235.6.44005 Boehringer Ingelheim Investigational Site
Chorley
1235.6.44002 Boehringer Ingelheim Investigational Site
Edgbaston, Birmingham
1235.6.44009 Boehringer Ingelheim Investigational Site
Ely
1235.6.44001 Boehringer Ingelheim Investigational Site
Fowey
1235.6.44003 Boehringer Ingelheim Investigational Site
Glasgow
1235.6.44012 Boehringer Ingelheim Investigational Site
Penzance
1235.6.44013 Boehringer Ingelheim Investigational Site
Plymouth
1235.6.44004 Boehringer Ingelheim Investigational Site
Reading
1235.6.44015 Boehringer Ingelheim Investigational Site
Saint Stephen, Saint Austell
1235.6.44014 Boehringer Ingelheim Investigational Site
Saltash
1235.6.44006 Boehringer Ingelheim Investigational Site
Whitstable

Other trials in United Kingdom

Ukraine13 sites

1235.6.38010 Boehringer Ingelheim Investigational Site
Dnipro
1235.6.38001 Boehringer Ingelheim Investigational Site
Kharkiv
1235.6.38003 Boehringer Ingelheim Investigational Site
Kharkiv
1235.6.38008 Boehringer Ingelheim Investigational Site
Kharkiv
1235.6.38011 Boehringer Ingelheim Investigational Site
Kharkiv
1235.6.38004 Boehringer Ingelheim Investigational Site
Kiev
1235.6.38006 Boehringer Ingelheim Investigational Site
Kiev
1235.6.38012 Boehringer Ingelheim Investigational Site
Kiev
1235.6.38013 Boehringer Ingelheim Investigational Site
Kiev
1235.6.38002 Boehringer Ingelheim Investigational Site
Lviv
1235.6.38005 Boehringer Ingelheim Investigational Site
Odesa
1235.6.38009 Boehringer Ingelheim Investigational Site
Odesa
1235.6.38007 Boehringer Ingelheim Investigational Site
Zaporizhzhya

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Bulgaria10 sites

1235.6.35912 Boehringer Ingelheim Investigational Site
Burgas
1235.6.35902 Boehringer Ingelheim Investigational Site
Sofia
1235.6.35903 Boehringer Ingelheim Investigational Site
Sofia
1235.6.35904 Boehringer Ingelheim Investigational Site
Sofia
1235.6.35905 Boehringer Ingelheim Investigational Site
Sofia
1235.6.35906 Boehringer Ingelheim Investigational Site
Sofia
1235.6.35907 Boehringer Ingelheim Investigational Site
Sofia
1235.6.35910 Boehringer Ingelheim Investigational Site
Sofia
1235.6.35911 Boehringer Ingelheim Investigational Site
Sofia
1235.6.35901 Boehringer Ingelheim Investigational Site
Varna

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Russia9 sites

1235.6.70004 Boehringer Ingelheim Investigational Site
Moscow
1235.6.70005 Boehringer Ingelheim Investigational Site
Moscow
1235.6.70006 Boehringer Ingelheim Investigational Site
Moscow
1235.6.70007 Boehringer Ingelheim Investigational Site
Moscow
1235.6.70008 Boehringer Ingelheim Investigational Site
Moscow
1235.6.70009 Boehringer Ingelheim Investigational Site
Moscow
1235.6.70010 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.6.70011 Boehringer Ingelheim Investigational Site
Saint Petersburg
1235.6.70012 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Czechia7 sites

1235.6.42002 Boehringer Ingelheim Investigational Site
Benátky nad Jizerou
1235.6.42006 Boehringer Ingelheim Investigational Site
Brno
1235.6.42001 Boehringer Ingelheim Investigational Site
Pilsen
1235.6.42003 Boehringer Ingelheim Investigational Site
Prague
1235.6.42004 Boehringer Ingelheim Investigational Site
Příbram
1235.6.42005 Boehringer Ingelheim Investigational Site
Slaný
1235.6.42007 Boehringer Ingelheim Investigational Site
Strakonice

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Slovakia7 sites

1235.6.42103 Boehringer Ingelheim Investigational Site
Dolný Kubín
1235.6.42106 Boehringer Ingelheim Investigational Site
Kralovsky Chmlec
1235.6.42104 Boehringer Ingelheim Investigational Site
Liptovský Mikuláš
1235.6.42102 Boehringer Ingelheim Investigational Site
Považská Bystrica
1235.6.42105 Boehringer Ingelheim Investigational Site
Prešov
1235.6.42101 Boehringer Ingelheim Investigational Site
Trenčín
1235.6.42107 Boehringer Ingelheim Investigational Site
Vráble

Other trials in Slovakia

Spain7 sites

1235.6.34008 Hospital Municipal de Badalona
Badalona
1235.6.34009 Boehringer Ingelheim Investigational Site
Barcelona
1235.6.34001 Hospital Gral de Jerez de la Frontera
Jerez de La Frontera (Cádiz)
1235.6.34006 C.A.P. Mossen Cinto Verdaguer
L'Hospitalet de Llobregat (Barcelona)
1235.6.34003 Hospital Doce de Octubre
Madrid
1235.6.34004 Hospital La Princesa
Madrid
1235.6.34011 Boehringer Ingelheim Investigational Site
Santa Coloma de Gramanet

Other trials in Spain

Austria6 sites

1235.6.43007 Boehringer Ingelheim Investigational Site
Eggenburg
1235.6.43006 Boehringer Ingelheim Investigational Site
Hainburg A.d. Donau
1235.6.43005 Boehringer Ingelheim Investigational Site
Hartberg
1235.6.43001 Boehringer Ingelheim Investigational Site
Vienna
1235.6.43002 Boehringer Ingelheim Investigational Site
Vienna
1235.6.43003 Boehringer Ingelheim Investigational Site
Vienna

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Ireland6 sites

1235.6.35304 Wilmer Road
Birr
1235.6.35305 Dr. Ger McLaughlin
Carrigtohill
1235.6.35302 Slaney Medical Centre
Enniscorthy
1235.6.35303 Gorey Medical Centre, Coral House,
Gorey
1235.6.35306 The Red House Surgery
Mallow
1235.6.35301 Boehringer Ingelheim Investigational Site
New Ross

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Australia5 sites

1235.6.61005 Boehringer Ingelheim Investigational Site
Elizabeth Vale, South Australia
1235.6.61003 Boehringer Ingelheim Investigational Site
Gosford, New South Wales
1235.6.61002 Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland
1235.6.61004 Boehringer Ingelheim Investigational Site
Liverpool, New South Wales
1235.6.61001 Boehringer Ingelheim Investigational Site
Milton, Queensland

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Turkey (Türkiye)4 sites

1235.6.90004 Boehringer Ingelheim Investigational Site
Erzurum
1235.6.90003 Boehringer Ingelheim Investigational Site
Istanbul
1235.6.90005 Boehringer Ingelheim Investigational Site
Istanbul
1235.6.90001 Boehringer Ingelheim Investigational Site
Izmir

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Italy3 sites

1235.6.39002 Boehringer Ingelheim Investigational Site
Broni (pv)
1235.6.39006 Boehringer Ingelheim Investigational Site
Coppito (AQ)
1235.6.39001 Boehringer Ingelheim Investigational Site
Ferrara

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New Zealand3 sites

1235.6.64003 Boehringer Ingelheim Investigational Site
Dunedin
1235.6.64002 Boehringer Ingelheim Investigational Site
Otahuhu, Auckland
1235.6.64001 Boehringer Ingelheim Investigational Site
Tauranga

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Switzerland1 site

1235.6.41005 Boehringer Ingelheim Investigational Site
Gordola

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About this study

Official title: An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy

Conditions: Hypertension
Being tested: fixed dose combination of telmisartan+amlodipine, amlodipine
Medical subject headings: Hypertension

What participants receive

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

fixed dose combination of telmisartan+amlodipineDrug
amlodipineDrug

What is being measured

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

Change From Baseline in Trough Seated Diastolic Blood Pressure
Change from baseline to the end of study in trough DBP
Measured: Baseline and end of study (8 weeks or last value on treatment)

Secondary outcomes (9)

Change From Baseline in Trough Seated Systolic Blood Pressure
Change from baseline to the end of study in trough SBP
Measured: Baseline and end of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)
The number of patients who reach the target DBP of <90mmHg
Measured: End of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure <80 mmHg
The number of patients who reach the target DBP of <80mmHg
Measured: End of study (8 weeks or last value on treatment)
Trough Seated DBP Response
The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg
Measured: End of study (8 weeks or last value on treatment)
Trough Seated SBP Control
The number of patients who reach the target SBP of <140mmHg
Measured: End of study (8 weeks or last value on treatment)
Trough Seated SBP Response
The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg
Measured: End of study (8 weeks or last value on treatment)
Trough Seated BP Normality Classes
The number of patients who reach predefined BP categories
Measured: End of study (8 weeks or last value on treatment)
Oedema Incidence Rate
The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)
Measured: During randomised treatment period
Peripheral Oedema Incidence Rate
The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)
Measured: During randomised treatment period

Timeline

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

Nov 2007Oct 2008

First posted5 Nov 2007 (estimated)
Study startNov 2007
Primary completionOct 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 Boehringer IngelheimThe 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
Intervention model: Parallel groups
Enrolment: 947 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00553267
Sponsor's protocol ID: 1235.6
Other IDs: EUDRACT 2007-002421-68
Status last verified: Dec 2013
First submitted: 8 Oct 2007
Last updated: 13 Feb 2014
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy
ClinicalTrials.gov ID: NCT00553267
Acronym / sponsor ID: 1235.6
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 947 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Oct 2008 (actual)
First posted: 5 Nov 2007 (estimated)
Results: Posted 22 Dec 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Intervention model: Parallel groups

Who may qualify

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

Key inclusion criteria (4 listed)

diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg if treatment-naïve).
failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP >= 90 mmHg.)
able to stop any current antihypertensive therapy without unacceptable risk to the patient.
willing and able to provide written informed consent.

Key exclusion criteria (18 listed)

pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
known or suspected secondary hypertension.
mean seated systolic blood pressure (SBP) >=200 mmHg and/or mean seated DBP >= 120 mmHg during run-in treatment or mean seated SBP >= 180 mmHg and/or mean seated DBP >= 120 mmHg at the randomisation visit or at any time during randomised treatment.
any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
clinically relevant hyperkalaemia.

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
fixed dose combination of telmisartan+amlodipine	Drug	–
amlodipine	Drug	–

Primary outcome

Change From Baseline in Trough Seated Diastolic Blood Pressure
Time frame: Baseline and end of study (8 weeks or last value on treatment)
Change from baseline to the end of study in trough DBP

9 secondary outcomes

Change From Baseline in Trough Seated Systolic Blood Pressure
Time frame: Baseline and end of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure <80 mmHg
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated DBP Response
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated SBP Control
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated SBP Response
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated BP Normality Classes
Time frame: End of study (8 weeks or last value on treatment)
Oedema Incidence Rate
Time frame: During randomised treatment period
Peripheral Oedema Incidence Rate
Time frame: During randomised treatment period

Results and safety

Results posted to the registry on 22 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine 10mg	315	301
Telmisartan 40mg and Amlodipine 10mg	315	297
Telmisartan 80mg and Amlodipine 10mg	317	307

Primary outcome: Change From Baseline in Trough Seated Diastolic Blood Pressure

Time frame: Baseline and end of study (8 weeks or last value on treatment). Least squares mean (Standard Error). Unit: mmHg

Measure	Amlodipine 10mg n = 305	Telmisartan 40mg and Amlodipine 10mg n = 306	Telmisartan 80mg and Amlodipine 10mg n = 310
Value	-6.48 (0.45)	-9.24 (0.45)	-9.33 (0.45)

Amlodipine 10mg vs Telmisartan 40mg and Amlodipine 10mg: Least Squares Mean Difference: -2.76 (95% CI -3.77 to -1.75), p <0.0001, ANCOVA
Amlodipine 10mg vs Telmisartan 80mg and Amlodipine 10mg: Least Squares Mean Difference: -2.85 (95% CI -3.86 to -1.84), p <0.0001, ANCOVA

Population analysed: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

9 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
Amlodipine 10mg	1 of ?	22 of ?	Not reported
Telmisartan 40mg and Amlodipine 10mg	3 of ?	21 of ?	Not reported
Telmisartan 80mg and Amlodipine 10mg	0 of ?	27 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

97 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fixed dose combination of telmisartan+amlodipine and amlodipine in people with Hypertension, run by Boehringer Ingelheim at 97 sites in 14 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 4 inclusion and 18 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United Kingdom, Ukraine, Bulgaria, Russia, Czechia and 9 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 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 22 Dec 2009). 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?

Change From Baseline in Trough Seated Diastolic Blood Pressure (time frame: Baseline and end of study (8 weeks or last value on treatment)). 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 NCT00553267.

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 13 Feb 2014.