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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239369
• Other study ID #: 502.480
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2005
• Last updated: December 27, 2017
• Start date: October 2005
• Est. completion date: August 2006

Study information

• Verified date: December 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 who fail to respond to six weeks treatment with T80/H12.5.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 713
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• 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.

• 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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Fixed dose combination telmisartan 80 mg + HCTZ 25 mg

• Fixed dose combination telmisartan 80 mg + HCTZ 12.5 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	Kokkola
Finland	Boehringer Ingelheim Investigational Site	Turku
Finland	Boehringer Ingelheim Investigational Site	Turku
France	ALTI	Angers
France	ALTI	Angers
France	Hopital Avicenne	Bobigny
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	Dublin 24
Ireland	Boehringer Ingelheim Investigational Site	Dublin 9
Ireland	Boehringer Ingelheim Investigational Site	Enniscorthy,
Ireland	Boehringer Ingelheim Investigational Site	Gorey
Ireland	Boehringer Ingelheim Investigational Site	Mallow
Ireland	Boehringer Ingelheim Investigational Site	New Ross
Ireland	Boehringer Ingelheim Investigational Site	Toomevara
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	Bennebroek
Netherlands	Boehringer Ingelheim Investigational Site	Ewijk
Netherlands	Boehringer Ingelheim Investigational Site	Helmond
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
Norway	Boehringer Ingelheim Investigational Site	Tolvsr?d
South Africa	Boehringer Ingelheim Investigational Site	Bellville
South Africa	Boehringer Ingelheim Investigational Site	Durban
South Africa	Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	Boehringer Ingelheim Investigational Site	Johannesburg
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	Pretoria
Spain	Hospital Municipal de Badalona	Badalona / Barcelona
Spain	Hospital de Galdakao	Galdakao / Vizcaya
Spain	Hospital Gral. Jerez de la Frontera	Jerez De La Frontera / Cadiz
Spain	C.A.P. Mosen Cinto Verdaguer	L'Hospitalet De Llobregat / Barcelona
Spain	Hospital Universitario Gregorio Mara?on	Madrid
Spain	C.A.P. Ronda Cerdanya	Mataro (Barcelona)
Spain	Hospital General 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	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
Taiwan	Boehringer Ingelheim Investigational Site	Taipei
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	Change from baseline in trough seated DBP		8 weeks
Secondary	Change from baseline in trough seated SBP		8 weeks
Secondary	Change from baseline in trough standing DBP and SBP		8 weeks
Secondary	The proportion of patients achieving DBP control (trough seated DBP<90 mmHg).		8 weeks
Secondary	The proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline =10 mmHg).		8 weeks
Secondary	The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline =10 mmHg).		8 weeks
Secondary	The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline =20 mmHg)		8 weeks
Secondary	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		8 weeks

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