Clinical trial NCT00558428: Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension
Official title: An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-11-15
Enrollment: 1098
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 objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.


Eligibility criteria: Inclusion Criteria:

1. patients aged at least 18 years at the date of signing the consent form
2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
4. able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Exclusion Criteria:

1. are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
2. known or suspected secondary hypertension
3. mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
4. any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
5. severe renal impairment (e.g. serum creatinine \>3.0 mg/dL or \>265 mcmol/L, known creatinine clearance \<30mL/min or clinical markers of severe renal impairment)
6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
7. clinically relevant hyperkalaemia
8. uncorrected volume or sodium depletion.
9. primary aldosteronism.
10. hereditary fructose or lactose intolerance

Primary outcomes:
measure: Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)
timeFrame: End of study (8 weeks or last value on treatment)
measure: Number of Patients With Oedema
timeFrame: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)
Secondary outcomes:
measure: Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)
timeFrame: End of study (8 weeks or last value on treatment)
measure: Trough Seated Diastolic Blood Pressure Control
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 Blood Pressure (BP) Normality Classes
timeFrame: End of study (8 weeks or last value on treatment)
Other outcomes:
Locations:
city: Aywaille
country: Belgium
facility: 1235.5.32004 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1235.5.32001 Boehringer Ingelheim Investigational Site
city: Gozée
country: Belgium
facility: 1235.5.32010 Boehringer Ingelheim Investigational Site
city: Linkebeek
country: Belgium
facility: 1235.5.32008 Boehringer Ingelheim Investigational Site
city: Mol
country: Belgium
facility: 1235.5.32003 Boehringer Ingelheim Investigational Site
city: Natoye
country: Belgium
facility: 1235.5.32007 Boehringer Ingelheim Investigational Site
city: Tavier
country: Belgium
facility: 1235.5.32009 Boehringer Ingelheim Investigational Site
city: Tienen-Kumtich
country: Belgium
facility: 1235.5.32002 Boehringer Ingelheim Investigational Site
city: Turnhout
country: Belgium
facility: 1235.5.32005 Boehringer Ingelheim Investigational Site
city: Coquitlam
country: Canada
facility: 1235.5.20001 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 1235.5.20011 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Bay Roberts
country: Canada
facility: 1235.5.20007 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: 1235.5.20005 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: 1235.5.20008 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Corunna
country: Canada
facility: 1235.5.20013 Boehringer Ingelheim Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: 1235.5.20014 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1235.5.20010 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1235.5.20012 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1235.5.20009 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: 1235.5.20006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: 1235.5.20003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Birkerød
country: Denmark
facility: 1235.5.45002 Boehringer Ingelheim Investigational Site
city: Haderslev
country: Denmark
facility: 1235.5.45005 Boehringer Ingelheim Investigational Site
city: Herning
country: Denmark
facility: 1235.5.45008 Boehringer Ingelheim Investigational Site
city: Hinnerup
country: Denmark
facility: 1235.5.45009 Boehringer Ingelheim Investigational Site
city: Rødovre
country: Denmark
facility: 1235.5.45001 Boehringer Ingelheim Investigational Site
city: Rødovre
country: Denmark
facility: 1235.5.45006 Boehringer Ingelheim Investigational Site
city: Vaerløse
country: Denmark
facility: 1235.5.45003 Boehringer Ingelheim Investigational Site
city: Vildbjerg
country: Denmark
facility: 1235.5.45007 Boehringer Ingelheim Investigational Site
city: Joensuu
country: Finland
facility: 1235.5.35003 Boehringer Ingelheim Investigational Site
city: Joensuu
country: Finland
facility: 1235.5.35004 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1235.5.35001 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1235.5.35002 Boehringer Ingelheim Investigational Site
city: Aigrefeuille S/Maine
country: France
facility: 1235.5.3301H Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1235.5.3306C Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1235.5.3309B Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1235.5.3309C Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1235.5.3309E Boehringer Ingelheim Investigational Site
city: Avrille
country: France
facility: 1235.5.3309D Boehringer Ingelheim Investigational Site
city: Beaucouze
country: France
facility: 1235.5.3309A Boehringer Ingelheim Investigational Site
city: Bourg des cptes
country: France
facility: 1235.5.3305A Boehringer Ingelheim Investigational Site
city: Briollay
country: France
facility: 1235.5.3306D Boehringer Ingelheim Investigational Site
city: Cholet
country: France
facility: 1235.5.3308B Boehringer Ingelheim Investigational Site
city: Cholet
country: France
facility: 1235.5.3308C Boehringer Ingelheim Investigational Site
city: Cholet
country: France
facility: 1235.5.3308D Boehringer Ingelheim Investigational Site
city: Cholet
country: France
facility: 1235.5.3308F Boehringer Ingelheim Investigational Site
city: Garchizy
country: France
facility: 1235.5.3302C Boehringer Ingelheim Investigational Site
city: Grandchamps
country: France
facility: 1235.5.3303C Boehringer Ingelheim Investigational Site
city: Guerigny
country: France
facility: 1235.5.3302D Boehringer Ingelheim Investigational Site
city: Jarny
country: France
facility: 1235.5.3310A Boehringer Ingelheim Investigational Site
city: La Chapelle /s Erdre
country: France
facility: 1235.5.3301L Boehringer Ingelheim Investigational Site
city: La Chapelle sur Erdre
country: France
facility: 1235.5.3301J Boehringer Ingelheim Investigational Site
city: La Fresnais
country: France
facility: 1235.5.3304A Boehringer Ingelheim Investigational Site
city: La Jubaudière
country: France
facility: 1235.5.3308E Boehringer Ingelheim Investigational Site
city: La Montagne
country: France
facility: 1235.5.3301G Boehringer Ingelheim Investigational Site
city: Le Bono
country: France
facility: 1235.5.3303B Boehringer Ingelheim Investigational Site
city: Le Mesnil en Vallée
country: France
facility: 1235.5.3307D Boehringer Ingelheim Investigational Site
city: Le Temple de Bretagne
country: France
facility: 1235.5.3301E Boehringer Ingelheim Investigational Site
city: Les Ponts de CE
country: France
facility: 1235.5.3309F Boehringer Ingelheim Investigational Site
city: Loudun
country: France
facility: 1235.5.3307G Boehringer Ingelheim Investigational Site
city: Louvigné le Bais
country: France
facility: 1235.5.3305B Boehringer Ingelheim Investigational Site
city: Mouliherne
country: France
facility: 1235.5.3307E Boehringer Ingelheim Investigational Site
city: Murs Erigne
country: France
facility: 1235.5.3306A Boehringer Ingelheim Investigational Site
city: Murs-Erigne
country: France
facility: 1235.5.3307A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1235.5.3301A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1235.5.3301B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1235.5.3301D Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1235.5.3301M Boehringer Ingelheim Investigational Site
city: Nevers
country: France
facility: 1235.5.3302A Boehringer Ingelheim Investigational Site
city: Nevers
country: France
facility: 1235.5.3302F Boehringer Ingelheim Investigational Site
city: Nort sur Erdre
country: France
facility: 1235.5.3301I Boehringer Ingelheim Investigational Site
city: Orvault
country: France
facility: 1235.5.3301C Boehringer Ingelheim Investigational Site
city: Parcay les Pins
country: France
facility: 1235.5.3307F Boehringer Ingelheim Investigational Site
city: Saint Pierre Montlimard
country: France
facility: 1235.5.3307C Boehringer Ingelheim Investigational Site
city: Sautron
country: France
facility: 1235.5.3301N Boehringer Ingelheim Investigational Site
city: Segre
country: France
facility: 1235.5.3306B Boehringer Ingelheim Investigational Site
city: St Aubin les Châteaux
country: France
facility: 1235.5.3301F Boehringer Ingelheim Investigational Site
city: St Georges de Montaigu
country: France
facility: 1235.5.3306F Boehringer Ingelheim Investigational Site
city: St Ouen La Rouerie
country: France
facility: 1235.5.3304B Boehringer Ingelheim Investigational Site
city: Thouars
country: France
facility: 1235.5.3306E Boehringer Ingelheim Investigational Site
city: Tinténiac
country: France
facility: 1235.5.3304C Boehringer Ingelheim Investigational Site
city: Vannes
country: France
facility: 1235.5.3303A Boehringer Ingelheim Investigational Site
city: Vihiers
country: France
facility: 1235.5.3308A Boehringer Ingelheim Investigational Site
city: Busan
country: Korea, Republic of
facility: 1235.5.82007 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 1235.5.82001 Boehringer Ingelheim Investigational Site
city: Daejon
country: Korea, Republic of
facility: 1235.5.82006 Boehringer Ingelheim Investigational Site
city: Gangwon-Do
country: Korea, Republic of
facility: 1235.5.82004 Boehringer Ingelheim Investigational Site
city: Gwangju
country: Korea, Republic of
facility: 1235.5.82008 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.5.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.5.82003 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.5.82005 Boehringer Ingelheim Investigational Site
city: Beerzerveld
country: Netherlands
facility: 1235.5.31008 Boehringer Ingelheim Investigational Site
city: Bennebroek
country: Netherlands
facility: 1235.5.31006 Boehringer Ingelheim Investigational Site
city: Hoogwoud
country: Netherlands
facility: 1235.5.31004 Boehringer Ingelheim Investigational Site
city: Musselkanaal
country: Netherlands
facility: 1235.5.31003 Boehringer Ingelheim Investigational Site
city: Nijverdal
country: Netherlands
facility: 1235.5.31007 Boehringer Ingelheim Investigational Site
city: Oude Pekela
country: Netherlands
facility: 1235.5.31001 Boehringer Ingelheim Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: 1235.5.31005 Boehringer Ingelheim Investigational Site
city: Voerendaal
country: Netherlands
facility: 1235.5.31010 Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: 1235.5.47002 Boehringer Ingelheim Investigational Site
city: Hamar
country: Norway
facility: 1235.5.47003 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1235.5.47004 Boehringer Ingelheim Investigational Site
city: Ålesund
country: Norway
facility: 1235.5.47001 Boehringer Ingelheim Investigational Site
city: Makati City
country: Philippines
facility: 1235.5.63006 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1235.5.63001 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1235.5.63002 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1235.5.63009 Boehringer Ingelheim Investigational Site
city: Pasay City
country: Philippines
facility: 1235.5.63008 Boehringer Ingelheim Investigational Site
city: Pasig City
country: Philippines
facility: 1235.5.63005 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1235.5.63003 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1235.5.63007 Boehringer Ingelheim Investigational Site
city: Boksburg
country: South Africa
facility: 1235.5.27003 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.5.27006 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.5.27009 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.5.27010 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1235.5.27004 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1235.5.27008 Boehringer Ingelheim Investigational Site
city: Krugersdorp
country: South Africa
facility: 1235.5.27001 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 1235.5.27005 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1235.5.27002 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1235.5.46002 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1235.5.46003 Boehringer Ingelheim Investigational Site
city: Luleå
country: Sweden
facility: 1235.5.46005 Boehringer Ingelheim Investigational Site
city: Rättvik
country: Sweden
facility: 1235.5.46004 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1235.5.46001 Boehringer Ingelheim Investigational Site
city: Changhua
country: Taiwan
facility: 1235.5.88605 Boehringer Ingelheim Investigational Site
city: Hualien City
country: Taiwan
facility: 1235.5.88608 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1235.5.88601 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1235.5.88603 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: