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

December 16, 2013 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

947

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia
        • 1235.6.61003 Boehringer Ingelheim Investigational Site
      • Liverpool, New South Wales, Australia
        • 1235.6.61004 Boehringer Ingelheim Investigational Site
    • Queensland
      • Kippa-Ring, Queensland, Australia
        • 1235.6.61002 Boehringer Ingelheim Investigational Site
      • Milton, Queensland, Australia
        • 1235.6.61001 Boehringer Ingelheim Investigational Site
    • South Australia
      • Elizabeth Vale, South Australia, Australia
        • 1235.6.61005 Boehringer Ingelheim Investigational Site
  • Austria
      • Eggenburg, Austria
        • 1235.6.43007 Boehringer Ingelheim Investigational Site
      • Hainburg a.d. Donau, Austria
        • 1235.6.43006 Boehringer Ingelheim Investigational Site
      • Hartberg, Austria
        • 1235.6.43005 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1235.6.43001 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1235.6.43002 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1235.6.43003 Boehringer Ingelheim Investigational Site
  • Bulgaria
      • Bourgas, Bulgaria
        • 1235.6.35912 Boehringer Ingelheim Investigational Site
      • Sofia, 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
      • Varna, Bulgaria
        • 1235.6.35901 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Benatky nad Jizerou, Czech Republic
        • 1235.6.42002 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1235.6.42006 Boehringer Ingelheim Investigational Site
      • Plzen, Czech Republic
        • 1235.6.42001 Boehringer Ingelheim Investigational Site
      • Praha 5, Czech Republic
        • 1235.6.42003 Boehringer Ingelheim Investigational Site
      • Pribram, Czech Republic
        • 1235.6.42004 Boehringer Ingelheim Investigational Site
      • Slany, Czech Republic
        • 1235.6.42005 Boehringer Ingelheim Investigational Site
      • Strakonice, Czech Republic
        • 1235.6.42007 Boehringer Ingelheim Investigational Site
  • Ireland
      • Birr, Ireland
        • 1235.6.35304 Wilmer Road
      • Carrigtwohill, Ireland
        • 1235.6.35305 Dr. Ger McLaughlin
      • Enniscorthy, Ireland
        • 1235.6.35302 Slaney Medical Centre
      • Gorey, Ireland
        • 1235.6.35303 Gorey Medical Centre, Coral House,
      • Mallow, Ireland
        • 1235.6.35306 The Red House Surgery
      • New Ross, Ireland
        • 1235.6.35301 Boehringer Ingelheim Investigational Site
  • Italy
      • Broni (pv), Italy
        • 1235.6.39002 Boehringer Ingelheim Investigational Site
      • Coppito (AQ), Italy
        • 1235.6.39006 Boehringer Ingelheim Investigational Site
      • Ferrara, Italy
        • 1235.6.39001 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Dunedin, New Zealand
        • 1235.6.64003 Boehringer Ingelheim Investigational Site
      • Otahuhu, Auckland, New Zealand
        • 1235.6.64002 Boehringer Ingelheim Investigational Site
      • Tauranga, New Zealand
        • 1235.6.64001 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, 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
      • St. Petersburg, 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
  • Slovakia
      • Dolny Kubin, Slovakia
        • 1235.6.42103 Boehringer Ingelheim Investigational Site
      • Kralovsky Chmlec, Slovakia
        • 1235.6.42106 Boehringer Ingelheim Investigational Site
      • Liptovsky Mikulas, Slovakia
        • 1235.6.42104 Boehringer Ingelheim Investigational Site
      • Povazska Bystrica, Slovakia
        • 1235.6.42102 Boehringer Ingelheim Investigational Site
      • Presov, Slovakia
        • 1235.6.42105 Boehringer Ingelheim Investigational Site
      • Trencin, Slovakia
        • 1235.6.42101 Boehringer Ingelheim Investigational Site
      • Vrable, Slovakia
        • 1235.6.42107 Boehringer Ingelheim Investigational Site
  • Spain
      • Badalona, Spain
        • 1235.6.34008 Hospital Municipal de Badalona
      • Barcelona, Spain
        • 1235.6.34009 Boehringer Ingelheim Investigational Site
      • Jerez de la Frontera (Cádiz), Spain
        • 1235.6.34001 Hospital Gral de Jerez de la Frontera
      • L'Hospitalet de Llobregat (Barcelona), Spain
        • 1235.6.34006 C.A.P. Mossen Cinto Verdaguer
      • Madrid, Spain
        • 1235.6.34003 Hospital Doce de Octubre
      • Madrid, Spain
        • 1235.6.34004 Hospital La Princesa
      • Santa Coloma de Gramanet, Spain
        • 1235.6.34011 Boehringer Ingelheim Investigational Site
  • Switzerland
      • Gordola, Switzerland
        • 1235.6.41005 Boehringer Ingelheim Investigational Site
  • Turkey
      • Erzurum, Turkey
        • 1235.6.90004 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1235.6.90003 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1235.6.90005 Boehringer Ingelheim Investigational Site
      • Izmir, Turkey
        • 1235.6.90001 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • 1235.6.38010 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.6.38001 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.6.38003 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.6.38008 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.6.38011 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.6.38004 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.6.38006 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.6.38012 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.6.38013 Boehringer Ingelheim Investigational Site
      • Lvov, Ukraine
        • 1235.6.38002 Boehringer Ingelheim Investigational Site
      • Odessa, Ukraine
        • 1235.6.38005 Boehringer Ingelheim Investigational Site
      • Odessa, Ukraine
        • 1235.6.38009 Boehringer Ingelheim Investigational Site
      • Zaporozhye, Ukraine
        • 1235.6.38007 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Bexhill, United Kingdom
        • 1235.6.44010 Boehringer Ingelheim Investigational Site
      • Blackpool, United Kingdom
        • 1235.6.44008 Boehringer Ingelheim Investigational Site
      • Blackpool, United Kingdom
        • 1235.6.44016 Boehringer Ingelheim Investigational Site
      • Burbage, Hinkley, United Kingdom
        • 1235.6.44011 Boehringer Ingelheim Investigational Site
      • Chestfield, Whitstable, United Kingdom
        • 1235.6.44007 Boehringer Ingelheim Investigational Site
      • Chorley, United Kingdom
        • 1235.6.44005 Boehringer Ingelheim Investigational Site
      • Edgbaston, Birmingham, United Kingdom
        • 1235.6.44002 Boehringer Ingelheim Investigational Site
      • Ely, United Kingdom
        • 1235.6.44009 Boehringer Ingelheim Investigational Site
      • Fowey, United Kingdom
        • 1235.6.44001 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 1235.6.44003 Boehringer Ingelheim Investigational Site
      • Penzance, United Kingdom
        • 1235.6.44012 Boehringer Ingelheim Investigational Site
      • Plymouth, United Kingdom
        • 1235.6.44013 Boehringer Ingelheim Investigational Site
      • Reading, United Kingdom
        • 1235.6.44004 Boehringer Ingelheim Investigational Site
      • Saltash, United Kingdom
        • 1235.6.44014 Boehringer Ingelheim Investigational Site
      • St Stephen, St Austell, United Kingdom
        • 1235.6.44015 Boehringer Ingelheim Investigational Site
      • Whitstable, United Kingdom
        • 1235.6.44006 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Seated Diastolic Blood Pressure
Time Frame: Baseline and end of study (8 weeks or last value on treatment)
Change from baseline to the end of study in trough DBP
Baseline and end of study (8 weeks or last value on treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Seated DBP Response
Time Frame: 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
End of study (8 weeks or last value on treatment)
Trough Seated SBP Control
Time Frame: End of study (8 weeks or last value on treatment)
The number of patients who reach the target SBP of <140mmHg
End of study (8 weeks or last value on treatment)
Trough Seated SBP Response
Time Frame: 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
End of study (8 weeks or last value on treatment)
Change From Baseline in Trough Seated Systolic Blood Pressure
Time Frame: Baseline and end of study (8 weeks or last value on treatment)
Change from baseline to the end of study in trough SBP
Baseline and end of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)
Time Frame: End of study (8 weeks or last value on treatment)
The number of patients who reach the target DBP of <90mmHg
End of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure <80 mmHg
Time Frame: End of study (8 weeks or last value on treatment)
The number of patients who reach the target DBP of <80mmHg
End of study (8 weeks or last value on treatment)
Trough Seated BP Normality Classes
Time Frame: End of study (8 weeks or last value on treatment)
The number of patients who reach predefined BP categories
End of study (8 weeks or last value on treatment)
Oedema Incidence Rate
Time Frame: 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)
During randomised treatment period
Peripheral Oedema Incidence Rate
Time Frame: During randomised treatment period
The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)
During randomised treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 8, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1235.6
  • EUDRACT 2007-002421-68

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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