Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan

An observational study of Hypertension, run by Boehringer Ingelheim at 182 sites in Slovenia.

Completed

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

Trial summary

This post-marketing surveillance study is designed to supplement the data on efficacy and tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general practice conditions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
How many people: 1,856 participants
Where: 182 sitesSlovenia
Study dates: Sep 2008to Sep 2009
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 hypertension

Who may be able to join

Patients with essential hypertension (blood pressure (BP) higher or equal to 140/90 mmHg or higher or equal to 130/80 mmHg in case of diabetic patients)
Patients with hypertension under treatment with one or more antihypertensive drug

Who cannot join

Patients are excluded according to the summary of product characteristics (SmPC).

Trial locations and contacts

182 sites in 1 country.

City, postcode or hospital

182 sites in 1 country

Slovenia182 sites

Boehringer Ingelheim Investigational Site 34
?adca
Boehringer Ingelheim Investigational Site 1
Bánovce Nad Bebravou
Boehringer Ingelheim Investigational Site 2
Banská Bystrica
Boehringer Ingelheim Investigational Site 3
Banská Bystrica
Boehringer Ingelheim Investigational Site 4
Banská Bystrica
Boehringer Ingelheim Investigational Site 5
Banská Bystrica
Boehringer Ingelheim Investigational Site 6
Banská Bystrica
Boehringer Ingelheim Investigational Site 7
Banská Bystrica
Boehringer Ingelheim Investigational Site 8
Banská Bystrica
Boehringer Ingelheim Investigational Site 10
Bardejov
Boehringer Ingelheim Investigational Site 11
Bardejov
Boehringer Ingelheim Investigational Site 12
Bardejov
Boehringer Ingelheim Investigational Site 9
Bardejov
Boehringer Ingelheim Investigational Site 13
Bratislava
Boehringer Ingelheim Investigational Site 14
Bratislava
Boehringer Ingelheim Investigational Site 15
Bratislava
Boehringer Ingelheim Investigational Site 16
Bratislava
Boehringer Ingelheim Investigational Site 17
Bratislava
Boehringer Ingelheim Investigational Site 18
Bratislava
Boehringer Ingelheim Investigational Site 19
Bratislava
Boehringer Ingelheim Investigational Site 20
Bratislava
Boehringer Ingelheim Investigational Site 21
Bratislava
Boehringer Ingelheim Investigational Site 22
Bratislava
Boehringer Ingelheim Investigational Site 23
Bratislava
Boehringer Ingelheim Investigational Site 24
Bratislava
Boehringer Ingelheim Investigational Site 25
Bratislava
Boehringer Ingelheim Investigational Site 26
Bratislava
Boehringer Ingelheim Investigational Site 27
Bratislava
Boehringer Ingelheim Investigational Site 28
Bratislava
Boehringer Ingelheim Investigational Site 29
Brezno
Boehringer Ingelheim Investigational Site 30
Brezno
Boehringer Ingelheim Investigational Site 31
Brezno
Boehringer Ingelheim Investigational Site 32
Brezno
Boehringer Ingelheim Investigational Site 33
Byt?a
Boehringer Ingelheim Investigational Site 35
Dolný Kubín
Boehringer Ingelheim Investigational Site 36
Dubnica Nad Váhom
Boehringer Ingelheim Investigational Site 37
Dubnica Nad Váhom
Boehringer Ingelheim Investigational Site 38
Dunajská Streda
Boehringer Ingelheim Investigational Site 39
Dunajská Streda
Boehringer Ingelheim Investigational Site 40
Dunajská Streda
Boehringer Ingelheim Investigational Site 41
Dunajská Streda
Boehringer Ingelheim Investigational Site 42
Dunajská Streda
Boehringer Ingelheim Investigational Site 43
Dunajská Streda
Boehringer Ingelheim Investigational Site 44
Galanta
Boehringer Ingelheim Investigational Site 45
Galanta
Boehringer Ingelheim Investigational Site 46
Handlová
Boehringer Ingelheim Investigational Site 47
Hlohovec
Boehringer Ingelheim Investigational Site 48
Hlohovec
Boehringer Ingelheim Investigational Site 49
Hnús?a
Boehringer Ingelheim Investigational Site 50
Hurbanovo
Boehringer Ingelheim Investigational Site 51
Jesenské
Boehringer Ingelheim Investigational Site 52
Kezmarok
Boehringer Ingelheim Investigational Site 53
Kolárovo
Boehringer Ingelheim Investigational Site 54
Komárno
Boehringer Ingelheim Investigational Site 55
Komárno
Boehringer Ingelheim Investigational Site 56
Kosice
Boehringer Ingelheim Investigational Site 57
Kosice
Boehringer Ingelheim Investigational Site 58
Kosice
Boehringer Ingelheim Investigational Site 59
Kosice
Boehringer Ingelheim Investigational Site 60
Kosice
Boehringer Ingelheim Investigational Site 61
Kosice
Boehringer Ingelheim Investigational Site 62
Kosice
Boehringer Ingelheim Investigational Site 63
Kosice
Boehringer Ingelheim Investigational Site 64
Kosice
Boehringer Ingelheim Investigational Site 65
Kosice
Boehringer Ingelheim Investigational Site 66
Kosice
Boehringer Ingelheim Investigational Site 67
Kosice
Boehringer Ingelheim Investigational Site 68
Kosice
Boehringer Ingelheim Investigational Site 69
Kosice
Boehringer Ingelheim Investigational Site 70
Kosice
Boehringer Ingelheim Investigational Site 71
Krá?ovský Chlmec
Boehringer Ingelheim Investigational Site 72
Kysucké Nové Mesto
Boehringer Ingelheim Investigational Site 73
Kysucké Nové Mesto
Boehringer Ingelheim Investigational Site 74
Kysucké Nové Mesto
Boehringer Ingelheim Investigational Site 75
Levice
Boehringer Ingelheim Investigational Site 76
Levice
Boehringer Ingelheim Investigational Site 77
Levice
Boehringer Ingelheim Investigational Site 78
Lipany
Boehringer Ingelheim Investigational Site 79
Lu?enec
Boehringer Ingelheim Investigational Site 80
Lu?enec
Boehringer Ingelheim Investigational Site 81
Lu?enec
Boehringer Ingelheim Investigational Site 82
Lu?enec
Boehringer Ingelheim Investigational Site 83
Martin
Boehringer Ingelheim Investigational Site 84
Martin
Boehringer Ingelheim Investigational Site 85
Martin
Boehringer Ingelheim Investigational Site 86
Michalovce
Boehringer Ingelheim Investigational Site 87
Michalovce
Boehringer Ingelheim Investigational Site 88
Michalovce
Boehringer Ingelheim Investigational Site 89
Myjava
Boehringer Ingelheim Investigational Site 90
Námestovo
Boehringer Ingelheim Investigational Site 91
Nitra
Boehringer Ingelheim Investigational Site 92
Nitra
Boehringer Ingelheim Investigational Site 93
Nitra
Boehringer Ingelheim Investigational Site 94
Nitra
Boehringer Ingelheim Investigational Site 95
Nové Mesto Nad Váhom
Boehringer Ingelheim Investigational Site 96
Nové Mesto Nad Váhom
Boehringer Ingelheim Investigational Site 97
Nové Mesto Nad Váhom
Boehringer Ingelheim Investigational Site 100
Nové Zámky
Boehringer Ingelheim Investigational Site 101
Nové Zámky
Boehringer Ingelheim Investigational Site 98
Nové Zámky
Boehringer Ingelheim Investigational Site 99
Nové Zámky
Boehringer Ingelheim Investigational Site 102
Partizánske
Boehringer Ingelheim Investigational Site 103
Partizánske
Boehringer Ingelheim Investigational Site 104
Pezinok
Boehringer Ingelheim Investigational Site 105
Pies?any
Boehringer Ingelheim Investigational Site 106
Poprad
Boehringer Ingelheim Investigational Site 107
Poprad
Boehringer Ingelheim Investigational Site 108
Poprad
Boehringer Ingelheim Investigational Site 109
Povazská Bystrica
Boehringer Ingelheim Investigational Site 110
Povazská Bystrica
Boehringer Ingelheim Investigational Site 111
Presov
Boehringer Ingelheim Investigational Site 112
Presov
Boehringer Ingelheim Investigational Site 113
Presov
Boehringer Ingelheim Investigational Site 114
Presov
Boehringer Ingelheim Investigational Site 115
Prievidza
Boehringer Ingelheim Investigational Site 116
Prievidza
Boehringer Ingelheim Investigational Site 117
Prievidza
Boehringer Ingelheim Investigational Site 118
Rajec
Boehringer Ingelheim Investigational Site 119
Revúca
Boehringer Ingelheim Investigational Site 120
Revúca
Boehringer Ingelheim Investigational Site 121
Rimavská Sobota
Boehringer Ingelheim Investigational Site 122
Rimavská Sobota
Boehringer Ingelheim Investigational Site 123
Rimavská Sobota
Boehringer Ingelheim Investigational Site 124
Roz?ava
Boehringer Ingelheim Investigational Site 125
Roz?ava
Boehringer Ingelheim Investigational Site 126
Ruzomberok
Boehringer Ingelheim Investigational Site 127
Ruzomberok
Boehringer Ingelheim Investigational Site 128
Sa?a
Boehringer Ingelheim Investigational Site 129
Sa?a
Boehringer Ingelheim Investigational Site 130
Sa?a
Boehringer Ingelheim Investigational Site 131
Se?ovce
Boehringer Ingelheim Investigational Site 132
Se?ovce
Boehringer Ingelheim Investigational Site 133
Skalica
Boehringer Ingelheim Investigational Site 134
Snina
Boehringer Ingelheim Investigational Site 135
Snina
Boehringer Ingelheim Investigational Site 136
Spisská Nová Ves
Boehringer Ingelheim Investigational Site 137
Spisská Nová Ves
Boehringer Ingelheim Investigational Site 138
Stará ?ubov?a
Boehringer Ingelheim Investigational Site 139
Stará ?ubov?a
Boehringer Ingelheim Investigational Site 140
Stará ?ubov?a
Boehringer Ingelheim Investigational Site 141
Stropkov
Boehringer Ingelheim Investigational Site 142
Stúrovo
Boehringer Ingelheim Investigational Site 143
Surany
Boehringer Ingelheim Investigational Site 144
Surany
Boehringer Ingelheim Investigational Site 145
Svit
Boehringer Ingelheim Investigational Site 146
Topo??any
Boehringer Ingelheim Investigational Site 147
Torna?a
Boehringer Ingelheim Investigational Site 148
Trebisov
Boehringer Ingelheim Investigational Site 149
Trebisov
Boehringer Ingelheim Investigational Site 150
Trebisov
Boehringer Ingelheim Investigational Site 151
Tren?ín
Boehringer Ingelheim Investigational Site 152
Tren?ín
Boehringer Ingelheim Investigational Site 153
Tren?ín
Boehringer Ingelheim Investigational Site 154
Tren?ín
Boehringer Ingelheim Investigational Site 155
Trnava
Boehringer Ingelheim Investigational Site 156
Trnava
Boehringer Ingelheim Investigational Site 157
Trnava
Boehringer Ingelheim Investigational Site 158
Trnava
Boehringer Ingelheim Investigational Site 159
Trstená
Boehringer Ingelheim Investigational Site 160
Tur?ianske Teplice
Boehringer Ingelheim Investigational Site 161
Turzovka
Boehringer Ingelheim Investigational Site 162
Ve?ké Kapusany
Boehringer Ingelheim Investigational Site 163
Ve?ké Kapusany
Boehringer Ingelheim Investigational Site 164
Ve?ký Krtís
Boehringer Ingelheim Investigational Site 165
Ve?ký Krtís
Boehringer Ingelheim Investigational Site 166
Vráble
Boehringer Ingelheim Investigational Site 167
Vranov Nad Top?ou
Boehringer Ingelheim Investigational Site 168
Zarnovica
Boehringer Ingelheim Investigational Site 169
Zeliezovce
Boehringer Ingelheim Investigational Site 170
Zilina
Boehringer Ingelheim Investigational Site 171
Zilina
Boehringer Ingelheim Investigational Site 172
Zilina
Boehringer Ingelheim Investigational Site 173
Zilina
Boehringer Ingelheim Investigational Site 174
Zilina
Boehringer Ingelheim Investigational Site 175
Zilina
Boehringer Ingelheim Investigational Site 176
Zlaté Moravce
Boehringer Ingelheim Investigational Site 177
Zlaté Moravce
Boehringer Ingelheim Investigational Site 178
Zlaté Moravce
Boehringer Ingelheim Investigational Site 179
Zvolen
Boehringer Ingelheim Investigational Site 180
Zvolen
Boehringer Ingelheim Investigational Site 181
Zvolen
Boehringer Ingelheim Investigational Site 182
Zvolen

Other trials in Slovenia

About this study

Official title: Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan

The aim of the study is to investigate the effect of a six-month treatment with Micardis® / MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight reduction on blood pressure control.

In addition, the post-marketing surveillance study will provide information on the effects on target measurement of the Lifestyle education tool and various laboratory parameters produced by treatment with Micardis® and MicardisPlus® in an unselected patient population under general practice conditions.

Conditions: Hypertension
Medical subject headings: Hypertension

What participants receive

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

Study groups in NCT01108796
Study group	Role	What they receive
Patients at cardiovascular risk		Not described

What is being measured

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

Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline
Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Measured: 24 weeks (Visit 1 to Visit 3)
Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline
Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Measured: 24 weeks (Visit 1 to Visit 3)

Secondary outcomes (5)

Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)
Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Measured: 24 weeks (Visit 1 to Visit 3)
Changes in Laboratory Parameters:High Density Lipoprotein (HDL)
Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Measured: 24 weeks (Visit 1 to Visit 3)
Changes in Laboratory Parameters: Triglycerides
Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Measured: 24 weeks (Visit 1 to Visit 3)
Changes in Laboratory Parameters: Blood Glucose
Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Measured: 24 weeks (Visit 1 to Visit 3)
Assessment of Metabolic Effect
Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'
Measured: 24 weeks (Visit 1 to Visit 3)

Timeline

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

Sep 2008Sep 2009

First posted22 Apr 2010 (estimated)
Study startSep 2008
Primary completionSep 2009
Study completionSep 2009

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,856 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01108796
Sponsor's protocol ID: 502.579
Status last verified: Feb 2014
First submitted: 11 Mar 2010
Last updated: 10 Apr 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

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan
ClinicalTrials.gov ID: NCT01108796
Acronym / sponsor ID: 502.579
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 1,856 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 22 Apr 2010 (estimated)
Results: Posted 30 Dec 2011

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients at cardiovascular risk	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with hypertension

Key inclusion criteria (2 listed)

Patients with essential hypertension (blood pressure (BP) higher or equal to 140/90 mmHg or higher or equal to 130/80 mmHg in case of diabetic patients)
Patients with hypertension under treatment with one or more antihypertensive drug

Key exclusion criteria (1 listed)

Patients are excluded according to the summary of product characteristics (SmPC).

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

Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline
Time frame: 24 weeks (Visit 1 to Visit 3)
Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline
Time frame: 24 weeks (Visit 1 to Visit 3)
Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool

5 secondary outcomes

Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)
Time frame: 24 weeks (Visit 1 to Visit 3)
Changes in Laboratory Parameters:High Density Lipoprotein (HDL)
Time frame: 24 weeks (Visit 1 to Visit 3)
Changes in Laboratory Parameters: Triglycerides
Time frame: 24 weeks (Visit 1 to Visit 3)
Changes in Laboratory Parameters: Blood Glucose
Time frame: 24 weeks (Visit 1 to Visit 3)
Assessment of Metabolic Effect
Time frame: 24 weeks (Visit 1 to Visit 3)

Results and safety

Results posted to the registry on 30 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Micardis® (Telmisartan)	774	767
MicardisPlus® (Telmisartan Hydrochlorothiazide)	1,067	1,060

Primary outcome: Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline

Time frame: 24 weeks (Visit 1 to Visit 3). Mean (Standard Deviation). Unit: mmHg

Measure	Micardis® (Telmisartan) n = 711	MicardisPlus® (Telmisartan Hydrochlorothiazide) n = 966	Tool (With Lifestyle Education Tool on Weight Reduction) n = 1083	No Tool (Without Lifestyle Education Tool on Weight Reduction) n = 594
Value	-30.71 (17.81)	-30.32 (15.05)	-30.35 (16.11)	-30.73 (16.58)

Primary outcome: Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline

Time frame: 24 weeks (Visit 1 to Visit 3). Mean (Standard Deviation). Unit: mmHg

Measure	Micardis® (Telmisartan) n = 711	MicardisPlus® (Telmisartan Hydrochlorothiazide) n = 966	Tool (With Lifestyle Education Tool on Weight Reduction) n = 1083	No Tool (Without Lifestyle Education Tool on Weight Reduction) n = 594
Value	-14.73 (8.75)	-15.31 (8.87)	-15.29 (8.85)	-14.65 (8.76)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks/ 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Micardis® (Telmisartan)	0 of 774 (0%)	0 of 774 (0%)	Not reported
MicardisPlus® (Telmisartan Hydrochlorothiazide)	1 of 1,067 (0.1%)	0 of 1,067 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, 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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 182 sites in Slovenia.

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 1 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 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in Slovenia. 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 30 Dec 2011). 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?

Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline (time frame: 24 weeks (Visit 1 to Visit 3)). 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 NCT01108796.

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 10 Apr 2014.