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

NCT ID: NCT00267943

Last Updated: 2013-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 639 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-01-31

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

telmisartan 80 mg + hydrochlorothiazide 25 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

BIL UK / Ireland

Locations

Boehringer Ingelheim Investigational Site

Birker?d, , Denmark

Boehringer Ingelheim Investigational Site

Haderslev, , Denmark

Boehringer Ingelheim Investigational Site

Odder, , Denmark

Boehringer Ingelheim Investigational Site

R?dovre, , Denmark

Boehringer Ingelheim Investigational Site

Vildbjerg, , Denmark

Boehringer Ingelheim Investigational Site

Helsinki, , Finland

Boehringer Ingelheim Investigational Site

Joensuu, , Finland

Boehringer Ingelheim Investigational Site

Turku, , Finland

Boehringer Ingelheim Investigational Site

Turku, , Finland

ALTI

Angers, , France

Hopital Avicenne

Bobigny, , France

Mg Recherches

Paris, , France

Mg Recherches

Paris, , France

Boehringer Ingelheim Investigational Site

Ellefeld, , Germany

Boehringer Ingelheim Investigational Site

Flörsheim, , Germany

Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Boehringer Ingelheim Investigational Site

Haag, , Germany

Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, , Germany

Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

Boehringer Ingelheim Investigational Site

Birr, , Ireland

Boehringer Ingelheim Investigational Site

Carrigallen, , Ireland

Boehringer Ingelheim Investigational Site

Dublin, , Ireland

Boehringer Ingelheim Investigational Site

Gorey, , Ireland

Boehringer Ingelheim Investigational Site

Mallow, , Ireland

Boehringer Ingelheim Investigational Site

New Ross, , Ireland

Boehringer Ingelheim Investigational Site

Templeshannon, , Ireland

Ospedale Arnaboldi

Broni (pv), , Italy

Azienda Ospedaliera Universita di Ferrara

Ferrara, , Italy

IRCCS San Raffaele

Roma, , Italy

Ospedale Civile

Vittorio Veneto (tv), , Italy

Boehringer Ingelheim Investigational Site

Kuching, Sarawak, , Malaysia

Boehringer Ingelheim Investigational Site

Beerzeveld, , Netherlands

Boehringer Ingelheim Investigational Site

Bennebroek, , Netherlands

Boehringer Ingelheim Investigational Site

Ewijk, , Netherlands

Boehringer Ingelheim Investigational Site

Hoogwoud, , Netherlands

Boehringer Ingelheim Investigational Site

Nijverdal, , Netherlands

Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

Boehringer Ingelheim Investigational Site

Rijswijk, , Netherlands

Boehringer Ingelheim Investigational Site

Roelofarendsveen, , Netherlands

Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

Boehringer Ingelheim Investigational Site

Elverum, , Norway

Boehringer Ingelheim Investigational Site

Moelv, , Norway

Boehringer Ingelheim Investigational Site

Oslo, , Norway

Boehringer Ingelheim Investigational Site

Skedsmokorset, , Norway

Boehringer Ingelheim Investigational Site

Bellville, , South Africa

Boehringer Ingelheim Investigational Site

Durban, , South Africa

Boehringer Ingelheim Investigational Site

Lenasia, , South Africa

Boehringer Ingelheim Investigational Site

Lenasia South, , South Africa

Boehringer Ingelheim Investigational Site

Midrand, , South Africa

Boehringer Ingelheim Investigational Site

Newtown, , South Africa

Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Boehringer Ingelheim Investigational Site

Soweto, , South Africa

Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Hospital Municipal de Badalona

Badalona, , Spain

Hospital de Galdakao

Galdakao / Vizcaya, , Spain

Hospital Gral de Jerez de la Frontera

Jerez de La Frontera / Cadiz, , Spain

C.A.P. Mosen Cinto Verdaguer

L'Hospitalet de Llobregat / Barcelona, , Spain

Hospital Univ. Gregorio Mara?on

Madrid, , Spain

C.A.P. Ronda Cerdanya

Mataro / Barcelona, , Spain

Hospital de Mostoles - Medicina Interna

Mostoles / Madrid, , Spain

Hospital del Conxo

Santiago de Compostela, , Spain

Boehringer Ingelheim Investigational Site

Eksjö, , Sweden

Boehringer Ingelheim Investigational Site

Karlstad, , Sweden

Boehringer Ingelheim Investigational Site

Karlstad, , Sweden

Boehringer Ingelheim Investigational Site

Uddevalla, , Sweden

Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Boehringer Ingelheim Investigational Site

Basel, , Switzerland

Boehringer Ingelheim Investigational Site

Basel, , Switzerland

Boehringer Ingelheim Investigational Site

Bellinzona, , Switzerland

Boehringer Ingelheim Investigational Site

Saint-Imier, , Switzerland

Boehringer Ingelheim Investigational Site

Vezia, , Switzerland

Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Countries

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

References

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.

Reference Type: DERIVED

PMID: 19191674 (View on PubMed)

Other Identifiers

502.491

Identifier Type: -

Identifier Source: org_study_id