Essential HypertensionNCT01127139

Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension

An observational study of Essential Hypertension, run by Abbott at 134 sites in Czechia.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Essential Hypertension
How many people: 3,828 participants
Where: 134 sitesCzechia
Study dates: Apr 2010to Mar 2011
Phase: Observational
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

Study population: Patients with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg

Who may be able to join

Men, women more than 18 years
Patients with uncontrolled essential hypertension eligible to Tarka treatment according to local label (BP ≥ 140/90 mmHg)
Patients providing oral informed consent (including consent of their medical data to be used for a Post Marketing Observational Study) and cooperating with physician
Patients who never received Tarka® in the past
Patients whom Tarka® will be prescribed according to the labelled indication and dose

Who cannot join

Patients contraindicated for treatment of Tarka® according to the local Summary of Product Characteristics (SmPC):
Hypersensitive to the active substances or to any of the inactive ingredients
With cardiogenic shock
With second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker
With sick sinus syndrome - except in patients with a functioning artificial pacemaker
With atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome

Show all 12Show fewer

With existing history of angioedema associated with administration of an ACE inhibitor
With severe renal (creatinine clearance < 10 ml/min) or severe liver impairment (cirrhosis with ascites)
Pregnant women, women of childbearing potential who are unwilling to use contraception
Lactating women
Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
Patients currently treated with other fixed antihypertensive combination

Trial locations and contacts

134 sites in 1 country.

City, postcode or hospital

134 sites in 1 country

Czechia134 sites

Site Reference ID/Investigator# 44896
Babice, 68703
Site Reference ID/Investigator# 40910
Beroun, 26601
Site Reference ID/Investigator# 40908
Bílovec, 74301
Site Reference ID/Investigator# 38816
Blansko, 678 01
Site Reference ID/Investigator# 41189
Brandýs nad Labem, 25001
Site Reference ID/Investigator# 40918
Břeclav, 690 02
Site Ref # / Investigator 40958
Brno, 602 00
Site Reference ID/Investigator# 40821
Brno, 602 00
Site Reference ID/Investigator# 40944
Brno, 602 00
Site Reference ID/Investigator# 41112
Brno, 602 00
Site Reference ID/Investigator# 41187
Brno, 602 00
Site Reference ID/Investigator# 41196
Brno, 602 00
Site Reference ID/Investigator# 44887
Brno, 60200
Site Reference ID/Investigator# 42083
Brumov, 76331
Site Reference ID/Investigator# 40967
Bruntál, 564 21
Site Reference ID/Investigator# 41119
Buštěhrad, 273 43
Site Reference ID/Investigator# 41195
Buštěhrad, 273 43
Site Reference ID/Investigator# 38836
Bystřice nad Pernštejnem, 593 01
Site Reference ID/Investigator# 41190
Bystřice nad Pernštejnem, 593 01
Site Ref # / Investigator 41626
C. Trebova, 779 00
Site Reference ID/Investigator# 41191
České Budějovice, 323 00
Site Ref # / Investigator 38710
České Budějovice, 370 01
Site Reference ID/Investigator# 40948
České Budějovice, 370 01
Site Reference ID/Investigator# 40960
České Budějovice, 370 01
Site Reference ID/Investigator# 40914
České Budějovice, 37001
Site Reference ID/Investigator# 57305
České Budějovice, 37001
Site Reference ID/Investigator# 42082
Cheb, 35002
Site Reference ID/Investigator# 38886
Děčín, 405 02
Site Reference ID/Investigator# 41110
Děčín, 405 02
Site Reference ID/Investigator# 40818
Děčín, 40501
Site Reference ID/Investigator# 40897
Děčín, 40502
Site Ref # / Investigator 40902
Děčín, 40505
Site Reference ID/Investigator# 41117
Hadačka, 33141
Site Reference ID/Investigator# 41103
Havířov, 736 01
Site Reference ID/Investigator# 40808
Havirov,Ostrava, 702 00
Site Reference ID/Investigator# 40909
Horní Slavkov, 35731
Site Reference ID/Investigator# 41185
Hradec Králové, 500 02
Site Reference ID/Investigator# 41188
Hradec Králové, 500 02
Site Reference ID/Investigator# 41197
Hranice, 753 01
Site Reference ID/Investigator# 40805
Hranice, 753 22
Site Reference ID/Investigator# 40815
Hranice U Asa, 354 15
Site Reference ID/Investigator# 38736
Jihlava, 586 01
Site Reference ID/Investigator# 38844
Karlovy Vary, 360 01
Site Reference ID/Investigator# 41184
Kdyně, 34 506
Site Reference ID/Investigator# 41113
Kladno, 272 01
Site Ref # / Investigator 44894
Kladno, 27280
Site Reference ID/Investigator# 40905
Kopřivnice, 74221
Site Ref # / Investigator 40961
Krnov, 779 00
Site Reference ID/Investigator# 40901
Kunovice, 68604
Site Reference ID/Investigator# 41192
Kutná Hora, 284 01
Site Reference ID/Investigator# 40811
Litomyšl, 570 01
Site Reference ID/Investigator# 41106
Litvínov, 43601
Site Reference ID/Investigator# 40904
Louny, 44001
Site Reference ID/Investigator# 40969
Lovosice, 41002
Site Reference ID/Investigator# 40953
Malšice, 370 01
Site Reference ID/Investigator# 41204
Mladá Boleslav, 293 60
Site Ref # / Investigator 44882
Mladá Boleslav, 29301
Site Reference ID/Investigator# 40804
Mnichovo Hradiště, 295 01
Site Ref # / Investigator 41118
Nový Jičín, 741 01
Site Reference ID/Investigator# 40954
Nový Jičín, 741 01
Site Ref # / Investigator 38569
Nymburk, 288 02
Site Reference ID/Investigator# 41114
Olomouc, 772 00
Site Reference ID/Investigator# 40949
Olomouc, 781 01
Site Reference ID/Investigator# 41107
Olomouc, 783 13
Site Ref # / Investigator 40907
Olomouc, 79401
Site Reference ID/Investigator# 41202
Orlová, 735 14
Site Reference ID/Investigator# 40816
Ostrava, 700 30
Site Reference ID/Investigator# 40951
Ostrava, 702 00
Site Reference ID/Investigator# 40972
Ostrava, 702 00
Site Reference ID/Investigator# 41194
Ostrava, 702 00
Site Reference ID/Investigator# 40968
Ostrava, 708 52
Site Reference ID/Investigator# 40945
Pardubice, 530 02
Site Reference ID/Investigator# 40957
Pardubice, 530 03
Site Reference ID/Investigator# 41201
Pardubice, 530 03
Site Reference ID/Investigator# 41205
Pardubice, 530 03
Site Reference ID/Investigator# 41625
Pardubice, 530 03
Site Reference ID/Investigator# 40956
Pilsen, 320 00
Site Reference ID/Investigator# 40896
Pilsen, 320 01
Site Ref # / Investigator 46282
Pilsen, 32000
Site Reference ID/Investigator# 40900
Plasy, 33101
Site Reference ID/Investigator# 41111
Poděbrady, 290 01
Site Ref # / Investigator 40911
Prachatice, 34142
Site Reference ID/Investigator# 41120
Prague, 110 00
Site Reference ID/Investigator# 41108
Prague, 120 00
Site Reference ID/Investigator# 40822
Prague, 128 08
Site Reference ID/Investigator# 44886
Prague, 13000
Site Ref # / Investigator 40819
Prague, 140 00
Site Reference ID/Investigator# 40817
Prague, 140 00
Site Reference ID/Investigator# 40812
Prague, 149 00
Site Reference ID/Investigator# 38628
Prague, 150 00
Site Reference ID/Investigator# 44883
Prague, 15000
Site Reference ID/Investigator# 41193
Prague, 160 00
Site Reference ID/Investigator# 44884
Prague, 16000
Site Reference ID/Investigator# 40917
Prague, 169 00
Site Reference ID/Investigator# 40913
Prague, 180 00
Site Reference ID/Investigator# 41123
Prague, 180 00
Site Reference ID/Investigator# 41124
Prague, 180 00
Site Reference ID/Investigator# 40903
Prague, 18000
Site Reference ID/Investigator# 38630
Prague, 190 00
Site Reference ID/Investigator# 40802
Prague, 190 00
Site Reference ID/Investigator# 40823
Prague
Site Reference ID/Investigator# 41126
Přelouč, 535 01
Site Reference ID/Investigator# 41198
Přelouč, 535 01
Site Reference ID/Investigator# 40809
Příbram, 26101
Site Reference ID/Investigator# 40952
Rokycany, 337 22
Site Reference ID/Investigator# 44893
Slaný, 274 01
Site Reference ID/Investigator# 41109
Slatiňany, 538 21
Site Reference ID/Investigator# 40919
Smržovka, 468 51
Site Ref # / Investigator 40807
Stará Paka, 507 91
Site Reference ID/Investigator# 40814
Staré Město, 686 03
Site Reference ID/Investigator# 42085
Staré Město, 68601
Site Reference ID/Investigator# 41104
Sternberk, 779 99
Site Reference ID/Investigator# 38746
Svitavy, 568 02
Site Reference ID/Investigator# 41121
Tábor, 370 01
Site Ref # / Investigator 40820
Teplice, 41501
Site Reference ID/Investigator# 41203
Třanovice, 739 53
Site Reference ID/Investigator# 38739
Třebíč, 674 01
Site Reference ID/Investigator# 40970
Třinec, 739 61
Site Reference ID/Investigator# 40971
Třinec, 739 61
Site Reference ID/Investigator# 41200
Třinec, 739 61
Site Reference ID/Investigator# 40895
Trutnov, 54121
Site Ref # / Investigator 40955
Turnov, 511 01
Site Reference ID/Investigator# 40959
Uherské Hradiště, 686 01
Site Reference ID/Investigator# 41182
Uherské Hradiště, 686 01
Site Reference ID/Investigator# 40906
Ústí nad Labem, 40001
Site Reference ID/Investigator# 41116
Ústí nad Labem, 40007
Site Reference ID/Investigator# 40950
Valašské Meziříčí, 757 01
Site Reference ID/Investigator# 40813
Vyškov, 682 01
Site Reference ID/Investigator# 41105
Vyškov, 682 01
Site Ref # / Investigator 41115
Zábřeh, 560 02
Site Reference ID/Investigator# 40916
Žamberk, 789 01
Site Reference ID/Investigator# 41186
Zdar, 591 01
Site Reference ID/Investigator# 42084
Zdar, 591 01
Site Reference ID/Investigator# 44895
Zlonice, 27371

Other trials in Czechia

About this study

Official title: Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With VerapamilSR/ Trandolapril Fixed Combination (Tarka®) in Patients With Essential Hypertension in Routine Clinical Practice

The fixed combination of verapamil SR/trandolapril (Tarka®) is an effective, well-tolerated therapy for the treatment of essential hypertension in those who require more than one agent to achieve optimal blood pressure (BP) control. The endpoint is compliance with Tarka® treatment by number/percentage of patients continued on fixed combination Tarka therapy after six months. This Post Marketing Observational Study will be conducted in a prospective, single-arm, single-country, multicenter format. The investigational sites will be the cardiologists, the doctors of internal medicine and general practicians. Since this will be a Post Marketing Observational Study, Tarka® will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as the local guidelines.

Read the detailed description

Follow-up of patients enables 4 patient visits during this period. For these reasons, the most likely visits are defined as "Inclusion visit" at which treatment with Tarka® is to be initiated, and then "Follow-up visit Week 4-6", "Follow-up visit Month 3 " and "Follow-up visit Month 6", although dates will depend only on the decision of the physician. For these reasons, the most likely visits are defined as "S/V" (Screening Visit), "F1" (Follow-up 1), "F2" (Follow-up 2), "F3" (Follow-up 3). The end point is compliance with Tarka® treatment by number/percentage of patients continued on fixed combination Tarka therapy after six months.

Conditions: Essential Hypertension
Keywords: Essential hypertension
Medical subject headings: Essential Hypertension

What participants receive

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

Study groups in NCT01127139
Study group	Role	What they receive
Czech patients with essential hypertension		Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.

What is being measured

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

Compliance With Tarka Treatment, All Participants and by Gender.
Participants were asked how many doses of Tarka they had missed after three months of treatment.
Measured: Month 3 Visit
Compliance With Tarka Treatment, All Participants and by Gender.
Participants were asked how many doses of Tarka they had missed since their previous visit.
Measured: Month 6 Visit

Secondary outcomes (6)

Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit.
Measured: Baseline to Month 6 Visit
Percentage of Patients Achieving Blood Pressure < 140/90 mmHg
The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.
Measured: Month 3 Visit
Percentage of Patients Achieving Blood Pressure < 140/90 mmHg
The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment.
Measured: Month 6 Visit
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
The number of participants at the Month 3 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach blood a pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.
Measured: Month 3 Visit
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
The number of participants at the Month 6 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach a blood pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.
Measured: Month 6 Visit
Adverse Events Leading to Study Discontinuation
The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized.
Measured: Baseline to Month 6 Visit

Timeline

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

Apr 2010Mar 2011

First posted20 May 2010 (estimated)
Study startApr 2010
Primary completionMar 2011
Study completionMar 2011

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 Essential HypertensionStudies of the same condition, open and under way.
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: Observational
Time perspective: Prospective
Enrolment: 3,828 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01127139
Sponsor's protocol ID: P12-161
Status last verified: Mar 2012
First submitted: 19 May 2010
Last updated: 1 May 2012
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

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With VerapamilSR/ Trandolapril Fixed Combination (Tarka®) in Patients With Essential Hypertension in Routine Clinical Practice
ClinicalTrials.gov ID: NCT01127139
Acronym / sponsor ID: P12-161
Conditions: Essential Hypertension
Keywords: Essential hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 3,828 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 20 May 2010 (estimated)
Results: Posted 1 May 2012

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

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Czech patients with essential hypertension	–	–Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg

Key inclusion criteria (5 listed)

Men, women more than 18 years
Patients with uncontrolled essential hypertension eligible to Tarka treatment according to local label (BP ≥ 140/90 mmHg)
Patients providing oral informed consent (including consent of their medical data to be used for a Post Marketing Observational Study) and cooperating with physician
Patients who never received Tarka® in the past
Patients whom Tarka® will be prescribed according to the labelled indication and dose

Key exclusion criteria (12 listed)

Patients contraindicated for treatment of Tarka® according to the local Summary of Product Characteristics (SmPC):
Hypersensitive to the active substances or to any of the inactive ingredients
With cardiogenic shock
With second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker
With sick sinus syndrome - except in patients with a functioning artificial pacemaker

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Compliance With Tarka Treatment, All Participants and by Gender.
Time frame: Month 3 Visit
Participants were asked how many doses of Tarka they had missed after three months of treatment.
Compliance With Tarka Treatment, All Participants and by Gender.
Time frame: Month 6 Visit
Participants were asked how many doses of Tarka they had missed since their previous visit.

6 secondary outcomes

Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline to Month 6 Visit
Percentage of Patients Achieving Blood Pressure < 140/90 mmHg
Time frame: Month 3 Visit
Percentage of Patients Achieving Blood Pressure < 140/90 mmHg
Time frame: Month 6 Visit
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Time frame: Month 3 Visit
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Time frame: Month 6 Visit
Adverse Events Leading to Study Discontinuation
Time frame: Baseline to Month 6 Visit

Results and safety

Results posted to the registry on 1 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Czech Patients With Essential Hypertension	3,828	3,771

Primary outcome: Compliance With Tarka Treatment, All Participants and by Gender.

Time frame: Month 3 Visit. Number. Unit: participants

Measure	Total n = 3828	Female Participants n = 1943	Male Participants n = 1885
Never missed a dose	2190	1141	1049
Missed one dose	1095	548	547
Missed two doses	446	213	233
Missed more than 2 doses	82	41	56

Population analysed: All participants with evaluable case report forms were analyzed.

Primary outcome: Compliance With Tarka Treatment, All Participants and by Gender.

Time frame: Month 6 Visit. Number. Unit: participants

Measure	Total n = 3828	Female Participants n = 1943	Male Participants n = 1885
Never missed a dose	2239	1181	1058
Missed one dose	901	420	481
Missed two doses	495	253	242
Missed more than 2 doses	193	89	104

Population analysed: All participants with evaluable case report forms were analyzed.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were followed for a period of 6 months or until discontinuation of treatment.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Czech Patients With Essential Hypertension	0 of 3,828 (0%)	0 of 3,828 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Essential Hypertension

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension

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.

Adam Hloska, M.D. study director

Abbott

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

Questions about this trial

What is this clinical trial studying?

An observational study of Essential Hypertension, run by Abbott at 134 sites in Czechia.

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 5 inclusion and 12 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 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in Czechia. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2012). 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?

Compliance With Tarka Treatment, All Participants and by Gender. (time frame: Month 3 Visit). 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 NCT01127139.

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 1 May 2012.