Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
- Conditions
- Hypertension
- Registration Number
- NCT00553267
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 947
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change From Baseline in Trough Seated Diastolic Blood Pressure Baseline and end of study (8 weeks or last value on treatment) Change from baseline to the end of study in trough DBP
- Secondary Outcome Measures
Name Time Method Change From Baseline in Trough Seated Systolic Blood Pressure Baseline and end of study (8 weeks or last value on treatment) Change from baseline to the end of study in trough SBP
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) End of study (8 weeks or last value on treatment) The number of patients who reach the target DBP of \<90mmHg
Trough Seated Diastolic Blood Pressure <80 mmHg End of study (8 weeks or last value on treatment) The number of patients who reach the target DBP of \<80mmHg
Trough Seated DBP Response End of study (8 weeks or last value on treatment) The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
Trough Seated SBP Control End of study (8 weeks or last value on treatment) The number of patients who reach the target SBP of \<140mmHg
Trough Seated BP Normality Classes End of study (8 weeks or last value on treatment) The number of patients who reach predefined BP categories
Oedema Incidence Rate During randomised treatment period The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)
Peripheral Oedema Incidence Rate During randomised treatment period The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)
Trough Seated SBP Response End of study (8 weeks or last value on treatment) The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
Trial Locations
- Locations (97)
1235.6.35904 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.6.35304 Wilmer Road
🇮🇪Birr, Ireland
1235.6.35902 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.6.35905 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.6.61003 Boehringer Ingelheim Investigational Site
🇦🇺Gosford, New South Wales, Australia
1235.6.35903 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.6.35912 Boehringer Ingelheim Investigational Site
🇧🇬Bourgas, Bulgaria
1235.6.61002 Boehringer Ingelheim Investigational Site
🇦🇺Kippa-Ring, Queensland, Australia
1235.6.43003 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1235.6.34003 Hospital Doce de Octubre
🇪🇸Madrid, Spain
1235.6.42002 Boehringer Ingelheim Investigational Site
🇨🇿Benatky nad Jizerou, Czech Republic
1235.6.44016 Boehringer Ingelheim Investigational Site
🇬🇧Blackpool, United Kingdom
1235.6.44011 Boehringer Ingelheim Investigational Site
🇬🇧Burbage, Hinkley, United Kingdom
1235.6.44014 Boehringer Ingelheim Investigational Site
🇬🇧Saltash, United Kingdom
1235.6.38008 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.6.44006 Boehringer Ingelheim Investigational Site
🇬🇧Whitstable, United Kingdom
1235.6.44015 Boehringer Ingelheim Investigational Site
🇬🇧St Stephen, St Austell, United Kingdom
1235.6.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.6.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.6.43007 Boehringer Ingelheim Investigational Site
🇦🇹Eggenburg, Austria
1235.6.43006 Boehringer Ingelheim Investigational Site
🇦🇹Hainburg a.d. Donau, Austria
1235.6.43005 Boehringer Ingelheim Investigational Site
🇦🇹Hartberg, Austria
1235.6.42003 Boehringer Ingelheim Investigational Site
🇨🇿Praha 5, Czech Republic
1235.6.42004 Boehringer Ingelheim Investigational Site
🇨🇿Pribram, Czech Republic
1235.6.42007 Boehringer Ingelheim Investigational Site
🇨🇿Strakonice, Czech Republic
1235.6.35305 Dr. Ger McLaughlin
🇮🇪Carrigtwohill, Ireland
1235.6.42101 Boehringer Ingelheim Investigational Site
🇸🇰Trencin, Slovakia
1235.6.35302 Slaney Medical Centre
🇮🇪Enniscorthy, Ireland
1235.6.35306 The Red House Surgery
🇮🇪Mallow, Ireland
1235.6.35301 Boehringer Ingelheim Investigational Site
🇮🇪New Ross, Ireland
1235.6.42104 Boehringer Ingelheim Investigational Site
🇸🇰Liptovsky Mikulas, Slovakia
1235.6.41005 Boehringer Ingelheim Investigational Site
🇨🇭Gordola, Switzerland
1235.6.43002 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1235.6.42001 Boehringer Ingelheim Investigational Site
🇨🇿Plzen, Czech Republic
1235.6.43001 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1235.6.42105 Boehringer Ingelheim Investigational Site
🇸🇰Presov, Slovakia
1235.6.39001 Boehringer Ingelheim Investigational Site
🇮🇹Ferrara, Italy
1235.6.44001 Boehringer Ingelheim Investigational Site
🇬🇧Fowey, United Kingdom
1235.6.44003 Boehringer Ingelheim Investigational Site
🇬🇧Glasgow, United Kingdom
1235.6.44012 Boehringer Ingelheim Investigational Site
🇬🇧Penzance, United Kingdom
1235.6.44013 Boehringer Ingelheim Investigational Site
🇬🇧Plymouth, United Kingdom
1235.6.34004 Hospital La Princesa
🇪🇸Madrid, Spain
1235.6.35907 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.6.35906 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.6.35910 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.6.35901 Boehringer Ingelheim Investigational Site
🇧🇬Varna, Bulgaria
1235.6.42006 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1235.6.42005 Boehringer Ingelheim Investigational Site
🇨🇿Slany, Czech Republic
1235.6.35303 Gorey Medical Centre, Coral House,
🇮🇪Gorey, Ireland
1235.6.39006 Boehringer Ingelheim Investigational Site
🇮🇹Coppito (AQ), Italy
1235.6.39002 Boehringer Ingelheim Investigational Site
🇮🇹Broni (pv), Italy
1235.6.64002 Boehringer Ingelheim Investigational Site
🇳🇿Otahuhu, Auckland, New Zealand
1235.6.64003 Boehringer Ingelheim Investigational Site
🇳🇿Dunedin, New Zealand
1235.6.70004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.6.70005 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.6.64001 Boehringer Ingelheim Investigational Site
🇳🇿Tauranga, New Zealand
1235.6.70006 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.6.70007 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.6.70008 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.6.70009 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.6.70010 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.6.70011 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.6.34006 C.A.P. Mossen Cinto Verdaguer
🇪🇸L'Hospitalet de Llobregat (Barcelona), Spain
1235.6.42103 Boehringer Ingelheim Investigational Site
🇸🇰Dolny Kubin, Slovakia
1235.6.70012 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.6.42106 Boehringer Ingelheim Investigational Site
🇸🇰Kralovsky Chmlec, Slovakia
1235.6.42102 Boehringer Ingelheim Investigational Site
🇸🇰Povazska Bystrica, Slovakia
1235.6.34009 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1235.6.42107 Boehringer Ingelheim Investigational Site
🇸🇰Vrable, Slovakia
1235.6.34008 Hospital Municipal de Badalona
🇪🇸Badalona, Spain
1235.6.90005 Boehringer Ingelheim Investigational Site
🇹🇷Istanbul, Turkey
1235.6.34011 Boehringer Ingelheim Investigational Site
🇪🇸Santa Coloma de Gramanet, Spain
1235.6.90004 Boehringer Ingelheim Investigational Site
🇹🇷Erzurum, Turkey
1235.6.90003 Boehringer Ingelheim Investigational Site
🇹🇷Istanbul, Turkey
1235.6.38010 Boehringer Ingelheim Investigational Site
🇺🇦Dnepropetrovsk, Ukraine
1235.6.90001 Boehringer Ingelheim Investigational Site
🇹🇷Izmir, Turkey
1235.6.38012 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.6.38013 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.6.38005 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1235.6.38009 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1235.6.44010 Boehringer Ingelheim Investigational Site
🇬🇧Bexhill, United Kingdom
1235.6.44008 Boehringer Ingelheim Investigational Site
🇬🇧Blackpool, United Kingdom
1235.6.44005 Boehringer Ingelheim Investigational Site
🇬🇧Chorley, United Kingdom
1235.6.44007 Boehringer Ingelheim Investigational Site
🇬🇧Chestfield, Whitstable, United Kingdom
1235.6.44009 Boehringer Ingelheim Investigational Site
🇬🇧Ely, United Kingdom
1235.6.44004 Boehringer Ingelheim Investigational Site
🇬🇧Reading, United Kingdom
1235.6.61001 Boehringer Ingelheim Investigational Site
🇦🇺Milton, Queensland, Australia
1235.6.44002 Boehringer Ingelheim Investigational Site
🇬🇧Edgbaston, Birmingham, United Kingdom
1235.6.61004 Boehringer Ingelheim Investigational Site
🇦🇺Liverpool, New South Wales, Australia
1235.6.61005 Boehringer Ingelheim Investigational Site
🇦🇺Elizabeth Vale, South Australia, Australia
1235.6.35911 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.6.34001 Hospital Gral de Jerez de la Frontera
🇪🇸Jerez de la Frontera (Cádiz), Spain
1235.6.38002 Boehringer Ingelheim Investigational Site
🇺🇦Lvov, Ukraine
1235.6.38001 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.6.38011 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.6.38006 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.6.38007 Boehringer Ingelheim Investigational Site
🇺🇦Zaporozhye, Ukraine