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

NCT ID: NCT00239369

Last Updated: 2017-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

713 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Fixed dose combination telmisartan 80 mg + HCTZ 25 mg

Intervention Type DRUG

Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

BIL UK / Ireland

Locations

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Boehringer Ingelheim Investigational Site

Birker?d, , Denmark

Site Status

Boehringer Ingelheim Investigational Site

Haderslev, , Denmark

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Boehringer Ingelheim Investigational Site

Odder, , Denmark

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Boehringer Ingelheim Investigational Site

R?dovre, , Denmark

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Boehringer Ingelheim Investigational Site

Vildbjerg, , Denmark

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Boehringer Ingelheim Investigational Site

Helsinki, , Finland

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Boehringer Ingelheim Investigational Site

Joensuu, , Finland

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Boehringer Ingelheim Investigational Site

Kokkola, , Finland

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Boehringer Ingelheim Investigational Site

Turku, , Finland

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Boehringer Ingelheim Investigational Site

Turku, , Finland

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ALTI

Angers, , France

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ALTI

Angers, , France

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Hopital Avicenne

Bobigny, , France

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Mg Recherches

Paris, , France

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Boehringer Ingelheim Investigational Site

Ellefeld, , Germany

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Boehringer Ingelheim Investigational Site

Flörsheim, , Germany

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Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

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Boehringer Ingelheim Investigational Site

Haag, , Germany

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Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

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Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

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Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, , Germany

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Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

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Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

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Boehringer Ingelheim Investigational Site

Birr, , Ireland

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Boehringer Ingelheim Investigational Site

Carrigallen, , Ireland

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Boehringer Ingelheim Investigational Site

Dublin, , Ireland

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Boehringer Ingelheim Investigational Site

Enniscorthy, , Ireland

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Boehringer Ingelheim Investigational Site

Gorey, , Ireland

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Boehringer Ingelheim Investigational Site

Mallow, , Ireland

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Boehringer Ingelheim Investigational Site

New Ross, , Ireland

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Boehringer Ingelheim Investigational Site

Toomyvara, , Ireland

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Ospedale Arnaboldi

Broni (PV), , Italy

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Azienda Ospedaliera Universita di Ferrara

Ferrara, , Italy

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IRCCS San Raffaele

Roma, , Italy

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Ospedale Civile

Vittorio Veneto (TV), , Italy

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Boehringer Ingelheim Investigational Site

Kuching, Sarawak, , Malaysia

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Boehringer Ingelheim Investigational Site

Bennebroek, , Netherlands

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Boehringer Ingelheim Investigational Site

Ewijk, , Netherlands

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Boehringer Ingelheim Investigational Site

Helmond, , Netherlands

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Boehringer Ingelheim Investigational Site

Hoogwoud, , Netherlands

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Boehringer Ingelheim Investigational Site

Nijverdal, , Netherlands

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Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

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Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

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Boehringer Ingelheim Investigational Site

Rijswijk, , Netherlands

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Boehringer Ingelheim Investigational Site

Roelofarendsveen, , Netherlands

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Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

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Boehringer Ingelheim Investigational Site

Elverum, , Norway

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Boehringer Ingelheim Investigational Site

Moelv, , Norway

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Boehringer Ingelheim Investigational Site

Oslo, , Norway

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Boehringer Ingelheim Investigational Site

Skedsmokorset, , Norway

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Boehringer Ingelheim Investigational Site

Tolvsr?d, , Norway

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Boehringer Ingelheim Investigational Site

Bellville, , South Africa

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Boehringer Ingelheim Investigational Site

Durban, , South Africa

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Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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Boehringer Ingelheim Investigational Site

Lenasia, , South Africa

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Boehringer Ingelheim Investigational Site

Lenasia South, , South Africa

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Boehringer Ingelheim Investigational Site

Midrand, , South Africa

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Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

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Boehringer Ingelheim Investigational Site

Incheon, , South Korea

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Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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Hospital Municipal de Badalona

Badalona / Barcelona, , Spain

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Hospital de Galdakao

Galdakao / Vizcaya, , Spain

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Hospital Gral. Jerez de la Frontera

Jerez de La Frontera / Cadiz, , Spain

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C.A.P. Mosen Cinto Verdaguer

L'Hospitalet de Llobregat / Barcelona, , Spain

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Hospital Universitario Gregorio Mara?on

Madrid, , Spain

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C.A.P. Ronda Cerdanya

Mataro (Barcelona), , Spain

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Hospital General de Mostoles - Medicina Interna

Mostoles / Madrid, , Spain

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Hospital del Conxo

Santiago de Compostela, , Spain

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Boehringer Ingelheim Investigational Site

Eksjö, , Sweden

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Boehringer Ingelheim Investigational Site

Karlstad, , Sweden

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Boehringer Ingelheim Investigational Site

Karlstad, , Sweden

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Boehringer Ingelheim Investigational Site

Uddevalla, , Sweden

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Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

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Boehringer Ingelheim Investigational Site

Basel, , Switzerland

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Boehringer Ingelheim Investigational Site

Basel, , Switzerland

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Boehringer Ingelheim Investigational Site

Basel, , Switzerland

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Boehringer Ingelheim Investigational Site

Bellinzona, , Switzerland

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Boehringer Ingelheim Investigational Site

Saint-Imier, , Switzerland

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Boehringer Ingelheim Investigational Site

Vezia, , Switzerland

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Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

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Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

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Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

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Countries

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Singapore Denmark Finland France Germany Hong Kong Ireland Italy Malaysia Netherlands Norway South Africa South Korea Spain Sweden Switzerland Taiwan

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/18772643

Related Info

Other Identifiers

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502.480

Identifier Type: -

Identifier Source: org_study_id