Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

June 17, 2014 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1098

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

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

  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

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 (DBP)
Time Frame: End of study (8 weeks or last value on treatment)
Change from baseline to the end of study in trough DBP
End of study (8 weeks or last value on treatment)
Number of Patients With Oedema
Time Frame: 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)
Patients from the treated set who experienced at least one case of general oedema.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)
Time Frame: End of study (8 weeks or last value on treatment)
Change from baseline to the end of study in trough SBP
End of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure Control
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 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)
Trough Seated Blood Pressure (BP) Normality Classes
Time Frame: End of study (8 weeks or last value on treatment)

The number of patients who reach predefined BP categories:

  • Optimal - SBP<120 and DBP<80 mmHg
  • Normal - SBP<130 and DBP<85 mmHg
  • High-normal - SBP<140 DBP<90 mmHg
  • Stage 1 hypertension - SBP<160 and DBP<100
  • Stage 2 hypertension SBP>=160 and DBP>=100 mmHg
End of study (8 weeks or last value on treatment)

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

October 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 29, 2007

First Submitted That Met QC Criteria

November 14, 2007

First Posted (Estimate)

November 15, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1235.5
  • EUDRACT2007-002409-36

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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