Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00553267
First received: October 8, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: fixed dose combination of telmisartan+amlodipine
Drug: amlodipine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Trough Seated Diastolic Blood Pressure [ Time Frame: Baseline and end of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    Change from baseline to the end of study in trough DBP


Secondary Outcome Measures:
  • Change From Baseline in Trough Seated Systolic Blood Pressure [ Time Frame: Baseline and end of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    Change from baseline to the end of study in trough SBP

  • Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target DBP of <90mmHg

  • Trough Seated Diastolic Blood Pressure <80 mmHg [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target DBP of <80mmHg

  • Trough Seated DBP Response [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg

  • Trough Seated SBP Control [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target SBP of <140mmHg

  • Trough Seated SBP Response [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg

  • Trough Seated BP Normality Classes [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach predefined BP categories

  • Oedema Incidence Rate [ Time Frame: During randomised treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: During randomised treatment period ] [ Designated as safety issue: No ]
    The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)


Enrollment: 947
Study Start Date: November 2007
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553267

  Hide Study Locations
Locations
Australia, New South Wales
1235.6.61003 Boehringer Ingelheim Investigational Site
Gosford, New South Wales, Australia
1235.6.61004 Boehringer Ingelheim Investigational Site
Liverpool, New South Wales, Australia
Australia, Queensland
1235.6.61002 Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland, Australia
1235.6.61001 Boehringer Ingelheim Investigational Site
Milton, Queensland, Australia
Australia, South Australia
1235.6.61005 Boehringer Ingelheim Investigational Site
Elizabeth Vale, South Australia, Australia
Austria
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
1235.6.43003 Boehringer Ingelheim Investigational Site
Wien, Austria
1235.6.43001 Boehringer Ingelheim Investigational Site
Wien, Austria
1235.6.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
Bulgaria
1235.6.35912 Boehringer Ingelheim Investigational Site
Bourgas, Bulgaria
1235.6.35902 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1235.6.35903 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1235.6.35904 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1235.6.35905 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1235.6.35906 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1235.6.35907 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1235.6.35910 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1235.6.35911 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1235.6.35901 Boehringer Ingelheim Investigational Site
Varna, Bulgaria
Czech Republic
1235.6.42002 Boehringer Ingelheim Investigational Site
Benatky nad Jizerou, Czech Republic
1235.6.42006 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1235.6.42001 Boehringer Ingelheim Investigational Site
Plzen, Czech Republic
1235.6.42003 Boehringer Ingelheim Investigational Site
Praha 5, Czech Republic
1235.6.42004 Boehringer Ingelheim Investigational Site
Pribram, Czech Republic
1235.6.42005 Boehringer Ingelheim Investigational Site
Slany, Czech Republic
1235.6.42007 Boehringer Ingelheim Investigational Site
Strakonice, Czech Republic
Ireland
1235.6.35304 Wilmer Road
Birr, Ireland
1235.6.35305 Dr. Ger McLaughlin
Carrigtwohill, Ireland
1235.6.35302 Slaney Medical Centre
Enniscorthy, Ireland
1235.6.35303 Gorey Medical Centre, Coral House,
Gorey, Ireland
1235.6.35306 The Red House Surgery
Mallow, Ireland
1235.6.35301 Boehringer Ingelheim Investigational Site
New Ross, Ireland
Italy
1235.6.39002 Boehringer Ingelheim Investigational Site
Broni (pv), Italy
1235.6.39006 Boehringer Ingelheim Investigational Site
Coppito (AQ), Italy
1235.6.39001 Boehringer Ingelheim Investigational Site
Ferrara, Italy
New Zealand
1235.6.64003 Boehringer Ingelheim Investigational Site
Dunedin, New Zealand
1235.6.64002 Boehringer Ingelheim Investigational Site
Otahuhu, Auckland, New Zealand
1235.6.64001 Boehringer Ingelheim Investigational Site
Tauranga, New Zealand
Russian Federation
1235.6.70004 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1235.6.70005 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
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
1235.6.70012 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Slovakia
1235.6.42103 Boehringer Ingelheim Investigational Site
Dolny Kubin, Slovakia
1235.6.42106 Boehringer Ingelheim Investigational Site
Kralovsky Chmlec, Slovakia
1235.6.42104 Boehringer Ingelheim Investigational Site
Liptovsky Mikulas, Slovakia
1235.6.42102 Boehringer Ingelheim Investigational Site
Povazska Bystrica, Slovakia
1235.6.42105 Boehringer Ingelheim Investigational Site
Presov, Slovakia
1235.6.42101 Boehringer Ingelheim Investigational Site
Trencin, Slovakia
1235.6.42107 Boehringer Ingelheim Investigational Site
Vrable, Slovakia
Spain
1235.6.34008 Hospital Municipal de Badalona
Badalona, Spain
1235.6.34009 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1235.6.34001 Hospital Gral de Jerez de la Frontera
Jerez de la Frontera (Cádiz), Spain
1235.6.34006 C.A.P. Mossen Cinto Verdaguer
L'Hospitalet de Llobregat (Barcelona), Spain
1235.6.34004 Hospital La Princesa
Madrid, Spain
1235.6.34003 Hospital Doce de Octubre
Madrid, Spain
1235.6.34011 Boehringer Ingelheim Investigational Site
Santa Coloma de Gramanet, Spain
Switzerland
1235.6.41005 Boehringer Ingelheim Investigational Site
Gordola, Switzerland
Turkey
1235.6.90004 Boehringer Ingelheim Investigational Site
Erzurum, Turkey
1235.6.90003 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1235.6.90005 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1235.6.90001 Boehringer Ingelheim Investigational Site
Izmir, Turkey
Ukraine
1235.6.38010 Boehringer Ingelheim Investigational Site
Dnepropetrovsk, Ukraine
1235.6.38008 Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
1235.6.38003 Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
1235.6.38001 Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
1235.6.38011 Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
1235.6.38004 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1235.6.38006 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1235.6.38013 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1235.6.38012 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1235.6.38002 Boehringer Ingelheim Investigational Site
Lvov, Ukraine
1235.6.38009 Boehringer Ingelheim Investigational Site
Odessa, Ukraine
1235.6.38005 Boehringer Ingelheim Investigational Site
Odessa, Ukraine
1235.6.38007 Boehringer Ingelheim Investigational Site
Zaporozhye, Ukraine
United Kingdom
1235.6.44010 Boehringer Ingelheim Investigational Site
Bexhill, United Kingdom
1235.6.44008 Boehringer Ingelheim Investigational Site
Blackpool, United Kingdom
1235.6.44016 Boehringer Ingelheim Investigational Site
Blackpool, United Kingdom
1235.6.44011 Boehringer Ingelheim Investigational Site
Burbage, Hinkley, United Kingdom
1235.6.44007 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable, United Kingdom
1235.6.44005 Boehringer Ingelheim Investigational Site
Chorley, United Kingdom
1235.6.44002 Boehringer Ingelheim Investigational Site
Edgbaston, Birmingham, United Kingdom
1235.6.44009 Boehringer Ingelheim Investigational Site
Ely, United Kingdom
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
1235.6.44004 Boehringer Ingelheim Investigational Site
Reading, United Kingdom
1235.6.44014 Boehringer Ingelheim Investigational Site
Saltash, United Kingdom
1235.6.44015 Boehringer Ingelheim Investigational Site
St Stephen, St Austell, United Kingdom
1235.6.44006 Boehringer Ingelheim Investigational Site
Whitstable, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00553267     History of Changes
Other Study ID Numbers: 1235.6, EUDRACT 2007-002421-68
Study First Received: October 8, 2007
Results First Received: November 18, 2009
Last Updated: December 16, 2013
Health Authority: Australia: Responsilble Ethics Committee
Austria: Federal Office for Safety in Health Care
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Great Britain: MHRA
Ireland: Irish Medicines Board
Italy: Comitato Etico della provinciale di Ferrara
New Zealand: Multicentre Ethics Committee/Medsafe
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Spain: Agencia Española del Medicamento y Productos Sanitarios
Switzerland: Swissmedic, Hallerstrasse 7, 3000 Bern
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Benzoates
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 23, 2014