Clinical trial NCT00553267: Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
Official title: An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 947
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.


Eligibility criteria: Inclusion Criteria:

* diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) \>= 95 mmHg if on existing antihypertensive treatment or seated DBP \>= 100 mmHg if treatment-naïve).
* failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP \>= 90 mmHg.)
* able to stop any current antihypertensive therapy without unacceptable risk to the patient.
* willing and able to provide written informed consent.

Exclusion Criteria:

* pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
* known or suspected secondary hypertension.
* mean seated systolic blood pressure (SBP) \>=200 mmHg and/or mean seated DBP \>= 120 mmHg during run-in treatment or mean seated SBP \>= 180 mmHg and/or mean seated DBP \>= 120 mmHg at the randomisation visit or at any time during randomised treatment.
* any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
* clinically relevant hyperkalaemia.
* uncorrected volume or sodium depletion.
* primary aldosteronism.
* hereditary fructose or lactose intolerance.
* symptomatic congestive heart failure.
* patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARBs.
* history of drug or alcohol dependency within the six months prior to signing consent.
* concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent.
* hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
* known allergic hypersensitivity to any component of the formulations under investigation. (Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine CCBs.)
* non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period.
* current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period.
* chronic administration of any medication known to affect blood pressure, other than the trial medication.
* any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.

Primary outcomes:
measure: Change From Baseline in Trough Seated Diastolic Blood Pressure
timeFrame: Baseline and end of study (8 weeks or last value on treatment)
Secondary outcomes:
measure: Change From Baseline in Trough Seated Systolic Blood Pressure
timeFrame: Baseline and end of study (8 weeks or last value on treatment)
measure: Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)
timeFrame: End of study (8 weeks or last value on treatment)
measure: Trough Seated Diastolic Blood Pressure <80 mmHg
timeFrame: End of study (8 weeks or last value on treatment)
measure: Trough Seated DBP Response
timeFrame: End of study (8 weeks or last value on treatment)
measure: Trough Seated SBP Control
timeFrame: End of study (8 weeks or last value on treatment)
measure: Trough Seated SBP Response
timeFrame: End of study (8 weeks or last value on treatment)
measure: Trough Seated BP Normality Classes
timeFrame: End of study (8 weeks or last value on treatment)
measure: Oedema Incidence Rate
timeFrame: During randomised treatment period
measure: Peripheral Oedema Incidence Rate
timeFrame: During randomised treatment period
Other outcomes:
Locations:
city: Gosford
country: Australia
facility: 1235.6.61003 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Liverpool
country: Australia
facility: 1235.6.61004 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Kippa-Ring
country: Australia
facility: 1235.6.61002 Boehringer Ingelheim Investigational Site
state: Queensland
city: Milton
country: Australia
facility: 1235.6.61001 Boehringer Ingelheim Investigational Site
state: Queensland
city: Elizabeth Vale
country: Australia
facility: 1235.6.61005 Boehringer Ingelheim Investigational Site
state: South Australia
city: Eggenburg
country: Austria
facility: 1235.6.43007 Boehringer Ingelheim Investigational Site
city: Hainburg a.d. Donau
country: Austria
facility: 1235.6.43006 Boehringer Ingelheim Investigational Site
city: Hartberg
country: Austria
facility: 1235.6.43005 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1235.6.43001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1235.6.43002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1235.6.43003 Boehringer Ingelheim Investigational Site
city: Bourgas
country: Bulgaria
facility: 1235.6.35912 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.6.35902 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.6.35903 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.6.35904 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.6.35905 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.6.35906 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.6.35907 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.6.35910 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.6.35911 Boehringer Ingelheim Investigational Site
city: Varna
country: Bulgaria
facility: 1235.6.35901 Boehringer Ingelheim Investigational Site
city: Benatky nad Jizerou
country: Czech Republic
facility: 1235.6.42002 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1235.6.42006 Boehringer Ingelheim Investigational Site
city: Plzen
country: Czech Republic
facility: 1235.6.42001 Boehringer Ingelheim Investigational Site
city: Praha 5
country: Czech Republic
facility: 1235.6.42003 Boehringer Ingelheim Investigational Site
city: Pribram
country: Czech Republic
facility: 1235.6.42004 Boehringer Ingelheim Investigational Site
city: Slany
country: Czech Republic
facility: 1235.6.42005 Boehringer Ingelheim Investigational Site
city: Strakonice
country: Czech Republic
facility: 1235.6.42007 Boehringer Ingelheim Investigational Site
city: Birr
country: Ireland
facility: 1235.6.35304 Wilmer Road
city: Carrigtwohill
country: Ireland
facility: 1235.6.35305 Dr. Ger McLaughlin
city: Enniscorthy
country: Ireland
facility: 1235.6.35302 Slaney Medical Centre
city: Gorey
country: Ireland
facility: 1235.6.35303 Gorey Medical Centre, Coral House,
city: Mallow
country: Ireland
facility: 1235.6.35306 The Red House Surgery
city: New Ross
country: Ireland
facility: 1235.6.35301 Boehringer Ingelheim Investigational Site
city: Broni (pv)
country: Italy
facility: 1235.6.39002 Boehringer Ingelheim Investigational Site
city: Coppito (AQ)
country: Italy
facility: 1235.6.39006 Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: 1235.6.39001 Boehringer Ingelheim Investigational Site
city: Dunedin
country: New Zealand
facility: 1235.6.64003 Boehringer Ingelheim Investigational Site
city: Otahuhu, Auckland
country: New Zealand
facility: 1235.6.64002 Boehringer Ingelheim Investigational Site
city: Tauranga
country: New Zealand
facility: 1235.6.64001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.6.70004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.6.70005 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.6.70006 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.6.70007 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.6.70008 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.6.70009 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.6.70010 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.6.70011 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.6.70012 Boehringer Ingelheim Investigational Site
city: Dolny Kubin
country: Slovakia
facility: 1235.6.42103 Boehringer Ingelheim Investigational Site
city: Kralovsky Chmlec
country: Slovakia
facility: 1235.6.42106 Boehringer Ingelheim Investigational Site
city: Liptovsky Mikulas
country: Slovakia
facility: 1235.6.42104 Boehringer Ingelheim Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: 1235.6.42102 Boehringer Ingelheim Investigational Site
city: Presov
country: Slovakia
facility: 1235.6.42105 Boehringer Ingelheim Investigational Site
city: Trencin
country: Slovakia
facility: 1235.6.42101 Boehringer Ingelheim Investigational Site
city: Vrable
country: Slovakia
facility: 1235.6.42107 Boehringer Ingelheim Investigational Site
city: Badalona
country: Spain
facility: 1235.6.34008 Hospital Municipal de Badalona
city: Barcelona
country: Spain
facility: 1235.6.34009 Boehringer Ingelheim Investigational Site
city: Jerez de la Frontera (Cádiz)
country: Spain
facility: 1235.6.34001 Hospital Gral de Jerez de la Frontera
city: L'Hospitalet de Llobregat (Barcelona)
country: Spain
facility: 1235.6.34006 C.A.P. Mossen Cinto Verdaguer
city: Madrid
country: Spain
facility: 1235.6.34003 Hospital Doce de Octubre
city: Madrid
country: Spain
facility: 1235.6.34004 Hospital La Princesa
city: Santa Coloma de Gramanet
country: Spain
facility: 1235.6.34011 Boehringer Ingelheim Investigational Site
city: Gordola
country: Switzerland
facility: 1235.6.41005 Boehringer Ingelheim Investigational Site
city: Erzurum
country: Turkey
facility: 1235.6.90004 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1235.6.90003 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1235.6.90005 Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: 1235.6.90001 Boehringer Ingelheim Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: 1235.6.38010 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.6.38001 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.6.38003 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.6.38008 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.6.38011 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.6.38004 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.6.38006 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.6.38012 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.6.38013 Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: 1235.6.38002 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1235.6.38005 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1235.6.38009 Boehringer Ingelheim Investigational Site
city: Zaporozhye
country: Ukraine
facility: 1235.6.38007 Boehringer Ingelheim Investigational Site
city: Bexhill
country: United Kingdom
facility: 1235.6.44010 Boehringer Ingelheim Investigational Site
city: Blackpool
country: United Kingdom
facility: 1235.6.44008 Boehringer Ingelheim Investigational Site
city: Blackpool
country: United Kingdom
facility: 1235.6.44016 Boehringer Ingelheim Investigational Site
city: Burbage, Hinkley
country: United Kingdom
facility: 1235.6.44011 Boehringer Ingelheim Investigational Site
city: Chestfield, Whitstable
country: United Kingdom
facility: 1235.6.44007 Boehringer Ingelheim Investigational Site
city: Chorley
country: United Kingdom
facility: 1235.6.44005 Boehringer Ingelheim Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: 1235.6.44002 Boehringer Ingelheim Investigational Site
city: Ely
country: United Kingdom
facility: 1235.6.44009 Boehringer Ingelheim Investigational Site
city: Fowey
country: United Kingdom
facility: 1235.6.44001 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 1235.6.44003 Boehringer Ingelheim Investigational Site
city: Penzance
country: United Kingdom
facility: 1235.6.44012 Boehringer Ingelheim Investigational Site
city: Plymouth
country: United Kingdom
facility: 1235.6.44013 Boehringer Ingelheim Investigational Site
city: Reading
country: United Kingdom
facility: 1235.6.44004 Boehringer Ingelheim Investigational Site
city: Saltash
country: United Kingdom
facility: 1235.6.44014 Boehringer Ingelheim Investigational Site
city: St Stephen, St Austell
country: United Kingdom
facility: 1235.6.44015 Boehringer Ingelheim Investigational Site
city: Whitstable
country: United Kingdom
facility: 1235.6.44006 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: