AzTrials
AzTrials

HypertensionPhase 3NCT00239369

Telmisartan80/HCTZ25 Versus Telmisartan80/HCTZ12.5 in Hypertension Not Responding to Telmisartan80/HCTZ12.5

A Phase 3 study testing Fixed dose combination telmisartan 80 mg + HCTZ 25 mg and Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg in people with Hypertension, run by Boehringer Ingelheim at 84 sites in 16 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 a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior in reducing blood pressure after eight weeks compared with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) in patients… 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 telmisartan 80 mg + HCTZ 25 mg and Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg
How many people
713 participants
Where
84 sitesin 16 countries
Study dates
Oct 2005to Aug 2006
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Essential hypertension.
  • Currently taking between one and three antihypertensive medications at a stable dose for at least four weeks before Visit 1.
  • Blood pressure not adequately controlled on existing treatment before entry (inadequate control defined as seated DBP >= 95 mmHg on one current antihypertensive medication or DBP >= 90 mmHg on two or more current antihypertensive medication(s).
  • Failure to respond to six weeks treatment with T80/H12.5. (Failure to respond defined as seated DBP >= 90 mmHg at six weeks. This criterion will be assessed at Visit 3.)
  • Willing and able to provide written informed consent.

Who cannot join

  • Women of child-bearing potential NOT practising acceptable means of birth control, positive serum pregnancy test, breastfeeding.
  • Known or suspected secondary hypertension.
  • Mean SBP >= 200 mmHg.
  • Severe hepatic or renal impairment.
  • Bilateral renal artery stenosis (or in a solitary kidney), post-renal transplant or only one functioning kidney.
  • Clinically relevant hypokalaemia or hyperkalaemia.
Show all 16Show fewer
  • Uncorrected volume or sodium depletion, primary aldosteronism.
  • Hereditary fructose intolerance.
  • Previous symptoms of angioedema after ACE inhibitors or angiotensin-II receptor antagonists.
  • Drug or alcohol dependency within the previous six months.
  • Administration of any medication known to affect blood pressure.
  • Concurrent participation in another clinical trial or any investigational therapy.
  • Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
  • Allergic hypersensitivity to any component of the formulations under investigation.
  • Concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (less than 80% or more than 120%) during th e run-in treatment period.
  • Any other clinical condition which, in the opinion of the investigator, would not allow safe administration of telmisartan or hydrochlorothiazide.

Trial locations and contacts

84 sites in 16 countries.

84 sites in 16 countries

Netherlands10 sites

  • Boehringer Ingelheim Investigational Site

    Bennebroek, 2121 BB

  • Boehringer Ingelheim Investigational Site

    Ewijk, 6644 CL

  • Boehringer Ingelheim Investigational Site

    Helmond, 5704 CM

  • Boehringer Ingelheim Investigational Site

    Hoogwoud, 1817 BG

  • Boehringer Ingelheim Investigational Site

    Nijverdal, 7442 LS

  • Boehringer Ingelheim Investigational Site

    Oude Pekela, 9665 AR

  • Boehringer Ingelheim Investigational Site

    Oude Pekela, 9665 BJ

  • Boehringer Ingelheim Investigational Site

    Rijswijk, 2281 AK

  • Boehringer Ingelheim Investigational Site

    Roelofarendsveen, 2371 RB

  • Boehringer Ingelheim Investigational Site

    Rotterdam, 3082 DC

Other trials in Netherlands

Germany8 sites

  • Boehringer Ingelheim Investigational Site

    Ellefeld, 08236

  • Boehringer Ingelheim Investigational Site

    Flörsheim, 65439

  • Boehringer Ingelheim Investigational Site

    Frankfurt am Main, 60323

  • Boehringer Ingelheim Investigational Site

    Haag, 83527

  • Boehringer Ingelheim Investigational Site

    Ingelheim, 55218

  • Boehringer Ingelheim Investigational Site

    Nuremberg, 90402

  • Boehringer Ingelheim Investigational Site

    Rodgau-Dudenhofen, 63110

  • Boehringer Ingelheim Investigational Site

    Unterschneidheim, 73485

Other trials in Germany

Ireland8 sites

  • Boehringer Ingelheim Investigational Site

    Birr

  • Boehringer Ingelheim Investigational Site

    Carrigallen

  • Boehringer Ingelheim Investigational Site

    Dublin

  • Boehringer Ingelheim Investigational Site

    Enniscorthy

  • Boehringer Ingelheim Investigational Site

    Gorey

  • Boehringer Ingelheim Investigational Site

    Mallow

  • Boehringer Ingelheim Investigational Site

    New Ross

  • Boehringer Ingelheim Investigational Site

    Toomyvara

Other trials in Ireland

South Africa8 sites

  • Boehringer Ingelheim Investigational Site

    Bellville, 7531

  • Boehringer Ingelheim Investigational Site

    Durban, 4091

  • Boehringer Ingelheim Investigational Site

    Johannesburg, 2001

  • Boehringer Ingelheim Investigational Site

    Johannesburg, 2013

  • Boehringer Ingelheim Investigational Site

    Lenasia, 2033

  • Boehringer Ingelheim Investigational Site

    Lenasia South, 2033

  • Boehringer Ingelheim Investigational Site

    Midrand, 1685

  • Boehringer Ingelheim Investigational Site

    Pretoria, 0038

Other trials in South Africa

Spain8 sites

  • Hospital Municipal de Badalona

    Badalona / Barcelona, 08911

  • Hospital de Galdakao

    Galdakao / Vizcaya, 48680

  • Hospital Gral. Jerez de la Frontera

    Jerez de La Frontera / Cadiz, 11407

  • C.A.P. Mosen Cinto Verdaguer

    L'Hospitalet de Llobregat / Barcelona, 08902

  • Hospital Universitario Gregorio Mara?on

    Madrid, 28007

  • C.A.P. Ronda Cerdanya

    Mataro (Barcelona), 08303

  • Hospital General de Mostoles - Medicina Interna

    Mostoles / Madrid, 28935

  • Hospital del Conxo

    Santiago de Compostela, 15706

Other trials in Spain

Switzerland6 sites

  • Boehringer Ingelheim Investigational Site

    Basel, 4031

  • Boehringer Ingelheim Investigational Site

    Basel, 4051

  • Boehringer Ingelheim Investigational Site

    Basel, 4052

  • Boehringer Ingelheim Investigational Site

    Bellinzona, 6500

  • Boehringer Ingelheim Investigational Site

    Saint-Imier, 2610

  • Boehringer Ingelheim Investigational Site

    Vezia, 6943

Other trials in Switzerland

Denmark5 sites

  • Boehringer Ingelheim Investigational Site

    Birker?d, 3460

  • Boehringer Ingelheim Investigational Site

    Haderslev, DK-6100

  • Boehringer Ingelheim Investigational Site

    Odder, DK-8300

  • Boehringer Ingelheim Investigational Site

    R?dovre, DK-2610

  • Boehringer Ingelheim Investigational Site

    Vildbjerg, DK-7480

Other trials in Denmark

Finland5 sites

  • Boehringer Ingelheim Investigational Site

    Helsinki, FI-00500

  • Boehringer Ingelheim Investigational Site

    Joensuu, FI-80100

  • Boehringer Ingelheim Investigational Site

    Kokkola, FI-67200

  • Boehringer Ingelheim Investigational Site

    Turku, FI-20100

  • Boehringer Ingelheim Investigational Site

    Turku, FI-20520

Other trials in Finland

Norway5 sites

  • Boehringer Ingelheim Investigational Site

    Elverum, N-2408

  • Boehringer Ingelheim Investigational Site

    Moelv, N-2391

  • Boehringer Ingelheim Investigational Site

    Oslo, N-0369

  • Boehringer Ingelheim Investigational Site

    Skedsmokorset, N-2020

  • Boehringer Ingelheim Investigational Site

    Tolvsr?d, N-3153

Other trials in Norway

Sweden5 sites

  • Boehringer Ingelheim Investigational Site

    Eksjö, 575 36

  • Boehringer Ingelheim Investigational Site

    Karlstad, 651 85

  • Boehringer Ingelheim Investigational Site

    Karlstad, 652 24

  • Boehringer Ingelheim Investigational Site

    Uddevalla, 451 40

  • Boehringer Ingelheim Investigational Site

    Uppsala, 751 25

Other trials in Sweden

France4 sites

  • ALTI

    Angers, 49000

  • ALTI

    Angers, 49100

  • Hopital Avicenne

    Bobigny, 93000

  • Mg Recherches

    Paris, 75015

Other trials in France

Italy4 sites

  • Ospedale Arnaboldi

    Broni (PV), 27043

  • Azienda Ospedaliera Universita di Ferrara

    Ferrara, 44100

  • IRCCS San Raffaele

    Roma, 00163

  • Ospedale Civile

    Vittorio Veneto (TV), 31029

Other trials in Italy

South Korea3 sites

  • Boehringer Ingelheim Investigational Site

    Incheon, 405760

  • Boehringer Ingelheim Investigational Site

    Seoul, 134701

  • Boehringer Ingelheim Investigational Site

    Seoul, 152703

Other trials in South Korea

Taiwan3 sites

  • Boehringer Ingelheim Investigational Site

    Taipei, 104

  • Boehringer Ingelheim Investigational Site

    Taipei, 112

  • Boehringer Ingelheim Investigational Site

    Taipei

Other trials in Taiwan

Hong Kong1 site

  • Boehringer Ingelheim Investigational Site

    Hong Kong

Other trials in Hong Kong

Malaysia1 site

  • Boehringer Ingelheim Investigational Site

    Kuching, Sarawak, 93586

Other trials in Malaysia

About this study

Official title: A Prospective Randomised Study to Compare a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 25 mg With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Uncontrolled Hypertension Who Fail to Respond Adequately to Treatment With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg

The primary objective of this trial is to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior in reducing blood pressure after eight weeks compared with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) in patients who fail to respond to six weeks treatment with T80/H12.5.

Read the detailed description

Adult patients with high blood pressure who are currently taking one, two or three blood pressure treatments will be asked to take part in the study. It is expected that about 1,600 patients in seventeen countries will enter the screening part of the study and approximately 480 of these patients will be allocated to double-blind randomised study treatment. The study will last for approximately fifteen weeks. Patients will visit the study doctor five times for assessment. After informed consent, patients will start a screening period for four to ten days. During the screening period, patients must take their usual blood pressure treatment but will stop this by the date of the next visit. If the patient is suitable for this study, they will then start run-in treatment period with telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) taken as a single tablet once per day for approximately six weeks.

At the end of the run-in treatment period, if the diastolic blood pressure (DBP) is below 90 mmHg, the patient will not proceed as their blood pressure is already controlled by T80/H12.5. If the DBP is 90 mmHg or greater they will start the randomised study treatment period and be randomly allocated to double-blind treatment with either telmisartan 80 mg plus hydrochlorothiazide 25 mg(T80/H25) or T80/H12.5 taken as a single tablet once per day for eight weeks. They will also receive a placebo tablet (a dummy tablet which contains no active ingredient) every day.

They will visit the clinic four weeks and eight weeks later for assessment of their blood pressure and general health. Their participation in the study is complete eight weeks after the start of the randomised treatment period.

Study Hypothesis:

The trial hypothesis is that the reduction in seated trough DBP (i.e., seated trough DBP at the end of the randomised treatment period compared with the seated trough DBP at the start of the randomised treatment period) will be greater in the T80/H25 group compared with the T80/H12.5 group.

Comparison(s):

The efficacy and safety of the two trial treatments (T80/H25 versus T80/H12.5) will be compared. Trough blood pressure is the blood pressure 24 hours after the last dose of trial medication.

Conditions
Hypertension
Being tested
Fixed dose combination telmisartan 80 mg + HCTZ 25 mg, Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg
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 telmisartan 80 mg + HCTZ 25 mgDrug

  • Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mgDrug

What is being measured

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

  1. Change from baseline in trough seated DBP

    Measured: 8 weeks

Secondary outcomes (7)

  1. Change from baseline in trough seated SBP

    Measured: 8 weeks

  2. Change from baseline in trough standing DBP and SBP

    Measured: 8 weeks

  3. The proportion of patients achieving DBP control (trough seated DBP<90 mmHg).

    Measured: 8 weeks

  4. The proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg).

    Measured: 8 weeks

  5. The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg).

    Measured: 8 weeks

  6. The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg)

    Measured: 8 weeks

  7. The proportion of patients in trough seated BP categories: opt.: SBP<120 mmHg and DBP<80 mmHg., norm.: SBP<130 mmHg and DBP<85 mmHg and not optimal, high-normal: SBP<140 mmHg and DBP<90 mmHg and not optimal or normal, high: SBP ≥140 mmHg or DBP ≥90 mmHg

    Measured: 8 weeks

Timeline

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

  1. First posted17 Oct 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
713 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00239369
Sponsor's protocol ID
502.480
Status last verified
Dec 2017
First submitted
13 Oct 2005
Last updated
28 Dec 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fixed dose combination telmisartan 80 mg + HCTZ 25 mg and Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg in people with Hypertension, run by Boehringer Ingelheim at 84 sites in 16 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 5 inclusion and 16 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 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Netherlands, Germany, Ireland, South Africa, Spain and 11 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 DBP (time frame: 8 weeks). 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 NCT00239369.

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 28 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in