HypertensionPhase 4NCT00926289

Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

A Phase 4 study testing Telmisartan and Hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim at 106 sites in 8 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 T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and Diastolic Blood… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Telmisartan and Hydrochlorothiazide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 894 participants
Where: 106 sitesin 8 countries
Study dates: Jun 2009to Apr 2010
Phase: Phase 4
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

Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;
Age 18 years or older;
Patients with grade 2 or grade 3 hypertension as defined SBP>=160 mmHg and DBP>=100 mmHg at randomization
Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)

Who cannot join

Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial. The only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
Mean in-clinic seated cuff SBP>= 200 mmHg and/or DBP >=120 mmHg
Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 umol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney

Show all 23Show fewer

Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may be rechecked for suspected error in result)
Uncorrected sodium or volume depletion
Primary aldosteronism.
Hereditary fructose intolerance
Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.3)
Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period)
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin >=10%
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
History of drug or alcohol dependency within 6 months prior to signing the informed consent form
Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
Any investigational drug therapy within 1 month of signing the informed consent
Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication

Trial locations and contacts

106 sites in 8 countries.

Country

City, postcode or hospital

106 sites in 8 countries

France28 sites

502.550.3302D Boehringer Ingelheim Investigational Site
Aigrefeuille S/Maine
502.550.3305I Boehringer Ingelheim Investigational Site
Aix-en-Provence
502.550.3305G Boehringer Ingelheim Investigational Site
Aubagne
502.550.3301H Boehringer Ingelheim Investigational Site
Briollay
502.550.3301K Boehringer Ingelheim Investigational Site
Cholet
502.550.3302I Boehringer Ingelheim Investigational Site
Corsept
502.550.3302C Boehringer Ingelheim Investigational Site
Donges
502.550.3302B Boehringer Ingelheim Investigational Site
La Montagne
502.550.3306A Boehringer Ingelheim Investigational Site
Louvigné-de-Bais
502.550.3303A Boehringer Ingelheim Investigational Site
Marseille
502.550.3303D Boehringer Ingelheim Investigational Site
Marseille
502.550.3303F Boehringer Ingelheim Investigational Site
Marseille
502.550.3304A Boehringer Ingelheim Investigational Site
Marseille
502.550.3304D Boehringer Ingelheim Investigational Site
Marseille
502.550.3304F Boehringer Ingelheim Investigational Site
Marseille
502.550.3304J Boehringer Ingelheim Investigational Site
Marseille
502.550.3305A Boehringer Ingelheim Investigational Site
Marseille
502.550.3301A Boehringer Ingelheim Investigational Site
Mûrs-Erigné
502.550.3301I Boehringer Ingelheim Investigational Site
Mûrs-Erigné
502.550.3302A Boehringer Ingelheim Investigational Site
Nantes
502.550.3302E Boehringer Ingelheim Investigational Site
Nantes
502.550.3301E Boehringer Ingelheim Investigational Site
Parçay-les-Pins
502.550.3303C Boehringer Ingelheim Investigational Site
Roquevaire
502.550.3302G Boehringer Ingelheim Investigational Site
Saint Aubin Les Châteaux
502.550.3306F Boehringer Ingelheim Investigational Site
Saint-Jouan-des-Guérets
502.550.3301F Boehringer Ingelheim Investigational Site
Segré
502.550.3307A Boehringer Ingelheim Investigational Site
Thouars
502.550.3301J Boehringer Ingelheim Investigational Site
Vihiers

Other trials in France

United States18 sites

502.550.01004 Boehringer Ingelheim Investigational Site
Arlington, Virginia
502.550.01008 Boehringer Ingelheim Investigational Site
Athens, Alabama
502.550.01016 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
502.550.01005 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
502.550.01001 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
502.550.01003 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
502.550.01014 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
502.550.01007 Boehringer Ingelheim Investigational Site
Greensboro, North Carolina
502.550.01017 Boehringer Ingelheim Investigational Site
Houston, Texas
502.550.01020 Boehringer Ingelheim Investigational Site
Houston, Texas
502.550.01015 Boehringer Ingelheim Investigational Site
Lomita, California
502.550.01002 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
502.550.01019 Boehringer Ingelheim Investigational Site
Mobile, Alabama
502.550.01011 Boehringer Ingelheim Investigational Site
New Iberia, Louisiana
502.550.01009 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
502.550.01018 Boehringer Ingelheim Investigational Site
Olive Branch, Mississippi
502.550.01012 Boehringer Ingelheim Investigational Site
San Antonio, Texas
502.550.01006 Boehringer Ingelheim Investigational Site
St Louis, Missouri

Other trials in United States

South Korea13 sites

502.550.82008 Boehringer Ingelheim Investigational Site
Cheonan
502.550.82009 Boehringer Ingelheim Investigational Site
Daegu
502.550.82001 Boehringer Ingelheim Investigational Site
Goyang
502.550.82003 Boehringer Ingelheim Investigational Site
Gwangju
502.550.82002 Boehringer Ingelheim Investigational Site
Seoul
502.550.82005 Boehringer Ingelheim Investigational Site
Seoul
502.550.82006 Boehringer Ingelheim Investigational Site
Seoul
502.550.82007 Boehringer Ingelheim Investigational Site
Seoul
502.550.82011 Boehringer Ingelheim Investigational Site
Seoul
502.550.82012 Boehringer Ingelheim Investigational Site
Seoul
502.550.82013 Boehringer Ingelheim Investigational Site
Seoul
502.550.82004 Boehringer Ingelheim Investigational Site
Suwon
502.550.82010 Boehringer Ingelheim Investigational Site
Wŏnju

Other trials in South Korea

Romania11 sites

502.550.40002 Boehringer Ingelheim Investigational Site
Baia Mare Maramures
502.550.40003 Boehringer Ingelheim Investigational Site
Brăila
502.550.40001 Boehringer Ingelheim Investigational Site
Bucharest
502.550.40010 Boehringer Ingelheim Investigational Site
Bucharest
502.550.40012 Boehringer Ingelheim Investigational Site
Bucharest
502.550.40009 Boehringer Ingelheim Investigational Site
Cluj-Napoca
502.550.40011 Boehringer Ingelheim Investigational Site
Cluj-Napoca
502.550.40006 Boehringer Ingelheim Investigational Site
Iași
502.550.40004 Boehringer Ingelheim Investigational Site
Oradea
502.550.40005 Boehringer Ingelheim Investigational Site
Sibiu
502.550.40008 Boehringer Ingelheim Investigational Site
Tg. Mures

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Bulgaria10 sites

502.550.35901 Boehringer Ingelheim Investigational Site
Sofia
502.550.35902 Boehringer Ingelheim Investigational Site
Sofia
502.550.35903 Boehringer Ingelheim Investigational Site
Sofia
502.550.35904 Boehringer Ingelheim Investigational Site
Sofia
502.550.35905 Boehringer Ingelheim Investigational Site
Sofia
502.550.35908 Boehringer Ingelheim Investigational Site
Sofia
502.550.35909 Boehringer Ingelheim Investigational Site
Sofia
502.550.35910 Boehringer Ingelheim Investigational Site
Sofia
502.550.35911 Boehringer Ingelheim Investigational Site
Sofia
502.550.35906 Boehringer Ingelheim Investigational Site
Stara Zagora

Other trials in Bulgaria

Russia10 sites

502.550.07001 Boehringer Ingelheim Investigational Site
Moscow
502.550.07002 Boehringer Ingelheim Investigational Site
Moscow
502.550.07003 Boehringer Ingelheim Investigational Site
Moscow
502.550.07004 Boehringer Ingelheim Investigational Site
Moscow
502.550.07005 Boehringer Ingelheim Investigational Site
Moscow
502.550.07006 Boehringer Ingelheim Investigational Site
Moscow
502.550.07007 Boehringer Ingelheim Investigational Site
Saint Petersburg
502.550.07008 Boehringer Ingelheim Investigational Site
Saint Petersburg
502.550.07009 Boehringer Ingelheim Investigational Site
Saint Petersburg
502.550.07010 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

China8 sites

502.550.86004 Boehringer Ingelheim Investigational Site
Changsha
502.550.86003 Boehringer Ingelheim Investigational Site
Guangzhou, Guangdong Province
502.550.86008 Boehringer Ingelheim Investigational Site
Qingdao
502.550.86001 Boehringer Ingelheim Investigational Site
Shanghai
502.550.86002 Boehringer Ingelheim Investigational Site
Shanghai
502.550.86009 Boehringer Ingelheim Investigational Site
Shenyang
502.550.86007 Boehringer Ingelheim Investigational Site
Tianjin
502.550.86010 Boehringer Ingelheim Investigational Site
Zhengzhou

Other trials in China

Georgia8 sites

502.550.99501 Boehringer Ingelheim Investigational Site
Tbilisi
502.550.99502 Boehringer Ingelheim Investigational Site
Tbilisi
502.550.99503 Boehringer Ingelheim Investigational Site
Tbilisi
502.550.99504 Boehringer Ingelheim Investigational Site
Tbilisi
502.550.99505 Boehringer Ingelheim Investigational Site
Tbilisi
502.550.99506 Boehringer Ingelheim Investigational Site
Tbilisi
502.550.99507 Boehringer Ingelheim Investigational Site
Tbilisi
502.550.99508 Boehringer Ingelheim Investigational Site
Tbilisi

Other trials in Georgia

About this study

Official title: A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)

Conditions: Hypertension
Being tested: Telmisartan, Hydrochlorothiazide
Medical subject headings: Hypertension

What participants receive

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

TelmisartanDrug
Telmisartan 80mg
TelmisartanDrug
Telmisartan 80mg
HydrochlorothiazideDrug
Hydrochlorothiazide25mg

Study groups in NCT00926289
Study group	Role	What they receive
Telmisartan	Active comparator	Telmisartan 80 mg Receives: Drug: Telmisartan
Telmisartan/hydrochlorothiazide	Experimental	Telmisartan80mg/Hydrochlorothiazide25mg Receives: Drug: Telmisartan; Drug: Hydrochlorothiazide

What is being measured

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

Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7
The SBP value at baseline was subtracted from the SBP value at Week 7.
Measured: Baseline and Week 7

Secondary outcomes (14)

Change From Baseline in Mean Seated Trough Cuff SBP to Week 5
The SBP value at baseline was subtracted from the SBP value at Week 5.
Measured: Baseline and Week 5
Change From Baseline in Mean Seated Trough Cuff SBP to Week 3
The SBP value at baseline was subtracted from the SBP value at Week 3.
Measured: Baseline and Week 3
Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7
The DBP value at baseline was subtracted from the DBP value at Week 7.
Measured: Baseline and Week 7
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7
SBP control is defined as SBP < 140 mmHg.
Measured: Week 7 timepoint
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5
SBP control is defined as SBP < 140 mmHg
Measured: Week 5 timepoint
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3
SBP control is defined as SBP < 140 mmHg
Measured: Week 3 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7
DBP control is defined as DBP<90 mmHg
Measured: Week 7 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5
DBP control is defined as DBP<90 mmHg
Measured: Week 5 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3
DBP control is defined as DBP<90 mmHg
Measured: Week 3 timepoint
Number of Patients With Blood Pressure (BP) Control at Week 7
BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP
Measured: Week 7 timepoint
Number of Patients With BP Control at Week 7
BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP
Measured: Week 7 timepoint
Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7
SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg
Measured: Week 7 timepoint
Number of Participants With DBP Response at Week 7
DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg
Measured: Week 7 timepoint
BP Categories at Week 7
BP categories comprise:
- BP optimal (SBP <120 mmHg and DBP <80 mmHg)
- BP normal (SBP <130 mmHg and DBP <85 mmHg but not 'optimal')
- BP high normal (SBP <140 mmHg and DBP <90 mmHg but not 'normal')
- Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not 'high normal')
- Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not 'Grade 1 hypertension')
- Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)
Measured: Week 7 timepoint

Timeline

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

Jun 2009Apr 2010

First posted23 Jun 2009 (estimated)
Study startJun 2009
Primary completionApr 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 894 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00926289
Sponsor's protocol ID: 502.550
Other IDs: 2008-007711-32, 2008
Status last verified: Dec 2013
First submitted: 22 Jun 2009
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Zhu DL, Bays H, Gao P, Mattheus M, Voelker B, Ruilope LM. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012 Jul;34(7):1613-24. doi: 10.1016/j.clinthera.2012.05.007. Epub 2012 Jun 19.
PubMed 22717420

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 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)
ClinicalTrials.gov ID: NCT00926289
Acronym / sponsor ID: 502.550
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 894 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Apr 2010 (actual)
First posted: 23 Jun 2009 (estimated)
Results: Posted 24 May 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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Telmisartan	Active comparator	Drug: TelmisartanTelmisartan 80 mg
Telmisartan/hydrochlorothiazide	Experimental	Drug: Telmisartan, Drug: HydrochlorothiazideTelmisartan80mg/Hydrochlorothiazide25mg

Who may qualify

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

Key inclusion criteria (4 listed)

Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;
Age 18 years or older;
Patients with grade 2 or grade 3 hypertension as defined SBP>=160 mmHg and DBP>=100 mmHg at randomization
Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)

Key exclusion criteria (23 listed)

Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial. The only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
Mean in-clinic seated cuff SBP>= 200 mmHg and/or DBP >=120 mmHg
Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 umol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.

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
TelmisartanTelmisartan 80mg	Drug	Telmisartan
TelmisartanTelmisartan 80mg	Drug	Telmisartan/hydrochlorothiazide
HydrochlorothiazideHydrochlorothiazide25mg	Drug	Telmisartan/hydrochlorothiazide

Primary outcome

Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7
Time frame: Baseline and Week 7
The SBP value at baseline was subtracted from the SBP value at Week 7.

14 secondary outcomes

Change From Baseline in Mean Seated Trough Cuff SBP to Week 5
Time frame: Baseline and Week 5
Change From Baseline in Mean Seated Trough Cuff SBP to Week 3
Time frame: Baseline and Week 3
Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7
Time frame: Baseline and Week 7
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7
Time frame: Week 7 timepoint
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5
Time frame: Week 5 timepoint
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3
Time frame: Week 3 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7
Time frame: Week 7 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5
Time frame: Week 5 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3
Time frame: Week 3 timepoint
Number of Patients With Blood Pressure (BP) Control at Week 7
Time frame: Week 7 timepoint
Number of Patients With BP Control at Week 7
Time frame: Week 7 timepoint
Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7
Time frame: Week 7 timepoint
Number of Participants With DBP Response at Week 7
Time frame: Week 7 timepoint
BP Categories at Week 7
Time frame: Week 7 timepoint

Results and safety

Results posted to the registry on 24 May 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
Telmisartan 40/80 mg	294	269
Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg	594	558

Primary outcome: Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7

Time frame: Baseline and Week 7. Least squares mean (Standard Error). Unit: mmHg

Measure	Telmisartan 40/80 mg n = 263	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n = 541
Value	-28.5 (0.88)	-37.0 (0.62)

Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Mean Difference (Final Values): -8.5 (95% CI -10.6 to -6.4), p <0.0001, ANCOVA

Population analysed: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan 40/80 mg	1 of 294 (0.3%)	0 of 294 (0%)	Not reported
Telmisartan 40/80 mg + HCTZ 12.5/25 mg	0 of 594 (0%)	0 of 594 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22717420Zhu DL, Bays H, Gao P, Mattheus M, Voelker B, Ruilope LM. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012 Jul;34(7):1613-24. doi: 10.1016/j.clinthera.2012.05.007. Epub 2012 Jun 19.
Related InfoLink provided by the sponsor.

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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

106 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telmisartan and Hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim at 106 sites in 8 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 23 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in France, United States, South Korea, Romania, Bulgaria and 3 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 24 May 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?

Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 (time frame: Baseline and Week 7). 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 NCT00926289, which also lists 1 linked publication.

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 27 Jun 2014.