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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267943
• Other study ID #: 502.491
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2005
• Last updated: November 12, 2013
• Start date: January 2006
• Est. completion date: January 2007

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesFrance: French Medicine Agency (AFSSAPS)Ireland: Irish Medicines BoardItaly: Ethics CommitteeNorway: Norwegian Medicines AgencyKorea, Republic of: Centre for Pharmaceutical Administration, Health Science AuthorityKorea, Republic of: National Pharmaceutical Control Bureau, MalaysiaKorea: Food and Drug AdministrationSwitzerland: SwissmedicSweden: LaekemedelsverketSouth Africa: Medicines Control CouncilDenmark: Laegemiddelstyrelsen Clinical StudiesGermany: Bundesministerium fuer Arzneimittel und MedizinprodukteNetherlands: No regulatory agency approval needed for clinical trialsFinland: Laeaekelaitos, National Agency for Medicines, Mannerheimintie 103b, P.O.Box 55, FI-00301
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 639
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• telmisartan 80 mg + hydrochlorothiazide 25 mg

Locations

Country	Name	City	State
Denmark	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
Finland	Boehringer Ingelheim Investigational Site	Helsinki
Finland	Boehringer Ingelheim Investigational Site	Joensuu
Finland	Boehringer Ingelheim Investigational Site	Turku
Finland	Boehringer Ingelheim Investigational Site	Turku
France	ALTI	Angers
France	Hopital Avicenne	Bobigny
France	Mg Recherches	Paris
France	Mg Recherches	Paris
Germany	Boehringer Ingelheim Investigational Site	Ellefeld
Germany	Boehringer Ingelheim Investigational Site	Florsheim
Germany	Boehringer Ingelheim Investigational Site	Frankfurt/Main
Germany	Boehringer Ingelheim Investigational Site	Haag
Germany	Boehringer Ingelheim Investigational Site	Ingelheim
Germany	Boehringer Ingelheim Investigational Site	Nurnberg
Germany	Boehringer Ingelheim Investigational Site	Rodgau-Dudenhofen
Germany	Boehringer Ingelheim Investigational Site	Unterschneidheim
Hong Kong	Boehringer Ingelheim Investigational Site	Hong Kong
Ireland	Boehringer Ingelheim Investigational Site	Birr
Ireland	Boehringer Ingelheim Investigational Site	Carrigallen
Ireland	Boehringer Ingelheim Investigational Site	Dublin 18
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
Italy	Ospedale Arnaboldi	Broni (pv)
Italy	Azienda Ospedaliera Universita di Ferrara	Ferrara
Italy	IRCCS San Raffaele	Roma
Italy	Ospedale Civile	Vittorio Veneto (tv)
Korea, Republic of	Boehringer Ingelheim Investigational Site	Incheon
Korea, Republic of	Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	Boehringer Ingelheim Investigational Site	Seoul
Malaysia	Boehringer Ingelheim Investigational Site	Kuching, Sarawak
Netherlands	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
Norway	Boehringer Ingelheim Investigational Site	Elverum
Norway	Boehringer Ingelheim Investigational Site	Moelv
Norway	Boehringer Ingelheim Investigational Site	Oslo
Norway	Boehringer Ingelheim Investigational Site	Skedsmokorset
South Africa	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
Spain	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
Sweden	Boehringer Ingelheim Investigational Site	Eksjo
Sweden	Boehringer Ingelheim Investigational Site	Karlstad
Sweden	Boehringer Ingelheim Investigational Site	Karlstad
Sweden	Boehringer Ingelheim Investigational Site	Uddevalla
Sweden	Boehringer Ingelheim Investigational Site	Uppsala
Switzerland	Boehringer Ingelheim Investigational Site	Basel
Switzerland	Boehringer Ingelheim Investigational Site	Basel
Switzerland	Boehringer Ingelheim Investigational Site	Bellinzona
Switzerland	Boehringer Ingelheim Investigational Site	St-Imier
Switzerland	Boehringer Ingelheim Investigational Site	Vezia
Taiwan	Boehringer Ingelheim Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose		at 6 months	No
Secondary	Change from baseline in trough seated DBP.		at 6 months	No
Secondary	Change from baseline in trough seated systolic blood pressure (SBP)		at 6 months	No
Secondary	Proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline =10 mmHg)		at 6 months	No
Secondary	Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline =10 mmHg)		at 6 months	No
Secondary	Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline =20 mmHg)		at 6 months	No
Secondary	Proportion of patients in the trough seated BP category optimal		at 6 months	No
Secondary	Proportion of patients in the trough seated BP category normal		at 6 months	No
Secondary	Proportion of patients in the trough seated BP category high-normal		at 6 months	No
Secondary	Proportion of patients in the trough seated BP category high		at 6 months	No
Secondary	Proportion of patients requiring additional antihypertensive therapy to achieve DBP control		at 6 months	No
Secondary	Additional reduction in BP by the use of additional antihypertensive therapy		at 6 months	No
Secondary	Time to starting additional antihypertensive therapy		within 6 months	No
Secondary	Incidence and intensity of Adverse events		6 month	No
Secondary	Physical examinations		6 month	No
Secondary	Change in laboratory parameters		6 month	No
Secondary	12-Lead Electrocardiogramm ECG		6 month	No
Secondary	Vital Signs (pulse rate, SBP, DBP)		6 month	No

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