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HypertensionPhase 3NCT00267943

Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients

A Phase 3 study testing telmisartan 80 mg + hydrochlorothiazide 25 mg in people with Hypertension, run by Boehringer Ingelheim at 78 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 is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment. 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 80 mg + hydrochlorothiazide 25 mg
How many people
639 participants
Where
78 sitesin 16 countries
Study dates
Jan 2006to Jan 2007
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 of preceding trial 502.480.
  • Blood pressure not adequately controlled on existing treatment before entry to preceding trial 502.480 (inadequate control defined as seated DBP >= 95 mmHg on one current antihypertensive medication or DBP >= 90 mmHg on two or more current antihypertensive medications).
  • Failure to respond to six weeks run-in treatment with T80/H12.5 in preceding trial 502.480. (Failure to respond defined as seated DBP >= 90 mmHg.)
  • 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.
  • Clinically significant change in ECG reported as adverse event in preceding trial 502.480.
  • Any medical condition developing in preceding trial 502.480 that could be worsened by telmisartan/HCTZ (80/25).
  • Discontinuation from preceding 502.480 trial for adverse event or any other reason.
  • Mean SBP >= 200 mmHg.
Show all 18Show fewer
  • 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 six months prior to entry to 502.480. 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 the preceding 502.480 trial.
  • Any other clinical condition which, in the opinion of the investigator, would not allow safe administration of telmisartan or hydrochlorothiazide.

Trial locations and contacts

78 sites in 16 countries.

78 sites in 16 countries

Netherlands10 sites

  • Boehringer Ingelheim Investigational Site

    Beerzeveld, 7685 PG

  • Boehringer Ingelheim Investigational Site

    Bennebroek, 2121 BB

  • Boehringer Ingelheim Investigational Site

    Ewijk, 6644 CL

  • Boehringer Ingelheim Investigational Site

    Hoogwoud, 1817 BG

  • Boehringer Ingelheim Investigational Site

    Nijverdal, 7441 BN

  • 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

South Africa8 sites

  • Boehringer Ingelheim Investigational Site

    Bellville, 7531

  • Boehringer Ingelheim Investigational Site

    Durban, 4001

  • Boehringer Ingelheim Investigational Site

    Lenasia, 2033

  • Boehringer Ingelheim Investigational Site

    Lenasia South, 2033

  • Boehringer Ingelheim Investigational Site

    Midrand, 1685

  • Boehringer Ingelheim Investigational Site

    Newtown, 2001

  • Boehringer Ingelheim Investigational Site

    Pretoria, 0038

  • Boehringer Ingelheim Investigational Site

    Soweto, 2000

Other trials in South Africa

Spain8 sites

  • Hospital Municipal de Badalona

    Badalona, 08911

  • Hospital de Galdakao

    Galdakao / Vizcaya, 48680

  • Hospital Gral de Jerez de la Frontera

    Jerez de La Frontera / Cadiz, 11407

  • C.A.P. Mosen Cinto Verdaguer

    L'Hospitalet de Llobregat / Barcelona, 08902

  • Hospital Univ. Gregorio Mara?on

    Madrid, 28007

  • C.A.P. Ronda Cerdanya

    Mataro / Barcelona, 08303

  • Hospital de Mostoles - Medicina Interna

    Mostoles / Madrid, 28935

  • Hospital del Conxo

    Santiago de Compostela, 15706

Other trials in Spain

Ireland7 sites

  • Boehringer Ingelheim Investigational Site

    Birr

  • Boehringer Ingelheim Investigational Site

    Carrigallen

  • Boehringer Ingelheim Investigational Site

    Dublin

  • Boehringer Ingelheim Investigational Site

    Gorey

  • Boehringer Ingelheim Investigational Site

    Mallow

  • Boehringer Ingelheim Investigational Site

    New Ross

  • Boehringer Ingelheim Investigational Site

    Templeshannon

Other trials in Ireland

Denmark5 sites

  • Boehringer Ingelheim Investigational Site

    Birker?d, 3460

  • Boehringer Ingelheim Investigational Site

    Haderslev, DK-6100

  • Boehringer Ingelheim Investigational Site

    Odder, 8300

  • Boehringer Ingelheim Investigational Site

    R?dovre, DK-2600

  • Boehringer Ingelheim Investigational Site

    Vildbjerg, DK-7480

Other trials in Denmark

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

Switzerland5 sites

  • Boehringer Ingelheim Investigational Site

    Basel, 4031

  • Boehringer Ingelheim Investigational Site

    Basel, 4051

  • Boehringer Ingelheim Investigational Site

    Bellinzona, 6500

  • Boehringer Ingelheim Investigational Site

    Saint-Imier, 2610

  • Boehringer Ingelheim Investigational Site

    Vezia, 6940

Other trials in Switzerland

Finland4 sites

  • Boehringer Ingelheim Investigational Site

    Helsinki, FI-00500

  • Boehringer Ingelheim Investigational Site

    Joensuu, FI-80100

  • Boehringer Ingelheim Investigational Site

    Turku, FI-20100

  • Boehringer Ingelheim Investigational Site

    Turku, FI-20520

Other trials in Finland

France4 sites

  • ALTI

    Angers, 49000

  • Hopital Avicenne

    Bobigny, 93000

  • Mg Recherches

    Paris, 75000

  • 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

Norway4 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

Other trials in Norway

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

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

Taiwan1 site

  • Boehringer Ingelheim Investigational Site

    Taipei, 112

Other trials in Taiwan

About this study

Official title: An Open-label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 80 mg + Hydrochlorothiazide 25 mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

The primary objective is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment.

Read the detailed description

Patients with a history of hypertension who completed a preceding trial (number 502.480) within the previous fourteen (14) days will be considered for entry to this long-term open-label trial. All patients will receive 'T80/H25'. Additional antihypertensive therapy will be allowed if the patients' blood pressure is not well controlled. [In the preceding double-blind trial 502.480, patients who failed to respond to the fixed dose combination of telmisartan 80 mg '+' hydrochlorothiazide 12.5 mg (T80/H12.5) were randomised to 'T80/H12.5' or T80H25 for eight weeks.] This is a multi-centre, multinational trial with approximately 80 study centres participating. Only study centres participating in the preceding trial 502.480 can enter patients into this open-label trial. It is anticipated that a maximum of 480 patients will be entered into the trial in seventeen countries. Each trial centre is expected to enter between four and twenty-four patients.

Enrollment of patients into this trial will finish when the last patient completes the preceding trial 502.480. At this time, centres will be notified of the termination of recruitment and will not be authorized to include any further patients.

Patients will visit the clinic one month, three months and six months later for assessment of their blood pressure and general health. Their participation in the study is complete six months after the start of the treatment period.

Study Hypothesis:

No statistical hypothesis will be tested. Descriptive statistics will be used to characterise the effects of treatment with T80/H25 with and without other antihypertensive treatments.

Comparison(s):

The proportion of patients achieving DBP control will be summarised by the total number of patients in the trial as well as by the maximum achieved dose level according to the two categories of T80/H25 alone (T80/H25) and with other antihypertensive medication added (T80/H25/other). An additional sub-group summary by the treatment group in the preceding trial 502.480 (T80/H12.5 and T80/H25) will also be presented.

Conditions
Hypertension
Being tested
telmisartan 80 mg + hydrochlorothiazide 25 mg
Medical subject headings
Hypertension

What participants receive

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

  • telmisartan 80 mg + hydrochlorothiazide 25 mgDrug

What is being measured

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

  1. Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose

    Measured: at 6 months

Secondary outcomes (17)

  1. Change from baseline in trough seated DBP.

    Measured: at 6 months

  2. Change from baseline in trough seated systolic blood pressure (SBP)

    Measured: at 6 months

  3. Proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg)

    Measured: at 6 months

  4. Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg)

    Measured: at 6 months

  5. Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg)

    Measured: at 6 months

  6. Proportion of patients in the trough seated BP category optimal

    Measured: at 6 months

  7. Proportion of patients in the trough seated BP category normal

    Measured: at 6 months

  8. Proportion of patients in the trough seated BP category high-normal

    Measured: at 6 months

  9. Proportion of patients in the trough seated BP category high

    Measured: at 6 months

  10. Proportion of patients requiring additional antihypertensive therapy to achieve DBP control

    Measured: at 6 months

  11. Additional reduction in BP by the use of additional antihypertensive therapy

    Measured: at 6 months

  12. Time to starting additional antihypertensive therapy

    Measured: within 6 months

  13. Incidence and intensity of Adverse events

    Measured: 6 month

  14. Physical examinations

    Measured: 6 month

  15. Change in laboratory parameters

    Measured: 6 month

  16. 12-Lead Electrocardiogramm ECG

    Measured: 6 month

  17. Vital Signs (pulse rate, SBP, DBP)

    Measured: 6 month

Timeline

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

  1. First posted22 Dec 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionJan 2007
  4. Study completionJan 2007

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
639 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00267943
Sponsor's protocol ID
502.491
Status last verified
Nov 2013
First submitted
21 Dec 2005
Last updated
13 Nov 2013
Results posted
No

Publications

  • Neldam S, Edwards C. Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication. Expert Opin Pharmacother. 2009 Feb;10(3):345-52. doi: 10.1517/14656560802707937.

    PubMed 19191674

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing telmisartan 80 mg + hydrochlorothiazide 25 mg in people with Hypertension, run by Boehringer Ingelheim at 78 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 18 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Netherlands, Germany, South Africa, Spain, Ireland 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?

Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose (time frame: at 6 months). 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 NCT00267943, 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 13 Nov 2013.

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