Open Label Study Telmisartan and Amlodipine in Hypertension

December 16, 2013 updated by: Boehringer Ingelheim

An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

976

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
        • 1235.7.32004 Boehringer Ingelheim Investigational Site
      • Gozée, Belgium
        • 1235.7.32010 Boehringer Ingelheim Investigational Site
      • Linkebeek, Belgium
        • 1235.7.32008 Boehringer Ingelheim Investigational Site
      • Mol, Belgium
        • 1235.7.32003 Boehringer Ingelheim Investigational Site
      • Natoye, Belgium
        • 1235.7.32007 Boehringer Ingelheim Investigational Site
      • Tienen, Belgium
        • 1235.7.32002 Boehringer Ingelheim Investigational Site
      • Turnhout, Belgium
        • 1235.7.32005 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • 1235.7.20001 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 1235.7.20011 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • 1235.7.20007 Boehringer Ingelheim Investigational Site
      • Mount Pearl, Newfoundland and Labrador, Canada
        • 1235.7.20005 Boehringer Ingelheim Investigational Site
      • St. John's, Newfoundland and Labrador, Canada
        • 1235.7.20008 Boehringer Ingelheim Investigational Site
    • Ontario
      • Corunna, Ontario, Canada
        • 1235.7.20013 Boehringer Ingelheim Investigational Site
      • Etobicoke, Ontario, Canada
        • 1235.7.20014 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1235.7.20010 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 1235.7.20012 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 1235.7.20009 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1235.7.20006 Boehringer Ingelheim Investigational Site
    • Quebec
      • Sainte-Foy, Quebec, Canada
        • 1235.7.20003 Boehringer Ingelheim Investigational Site
  • Denmark
      • Birkerød, Denmark
        • 1235.7.45002 Boehringer Ingelheim Investigational Site
      • Haderslev, Denmark
        • 1235.7.45005 Boehringer Ingelheim Investigational Site
      • Herning, Denmark
        • 1235.7.45008 Boehringer Ingelheim Investigational Site
      • Hinnerup, Denmark
        • 1235.7.45009 Boehringer Ingelheim Investigational Site
      • Rødovre, Denmark
        • 1235.7.45001 Boehringer Ingelheim Investigational Site
      • Rødovre, Denmark
        • 1235.7.45006 Boehringer Ingelheim Investigational Site
      • Vaerløse, Denmark
        • 1235.7.45003 Boehringer Ingelheim Investigational Site
      • Vildbjerg, Denmark
        • 1235.7.45007 Boehringer Ingelheim Investigational Site
  • Finland
      • Joensuu, Finland
        • 1235.7.35003 Boehringer Ingelheim Investigational Site
      • Joensuu, Finland
        • 1235.7.35004 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1235.7.35001 Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • 1235.7.35002 Boehringer Ingelheim Investigational Site
  • France
      • Aigrefeuille S/Maine, France
        • 1235.7.3301H Boehringer Ingelheim Investigational Site
      • Angers, France
        • 1235.7.3306C Boehringer Ingelheim Investigational Site
      • Angers, France
        • 1235.7.3309B Boehringer Ingelheim Investigational Site
      • Angers, France
        • 1235.7.3309C Boehringer Ingelheim Investigational Site
      • Angers, France
        • 1235.7.3309E Boehringer Ingelheim Investigational Site
      • Avrille, France
        • 1235.7.3309D Boehringer Ingelheim Investigational Site
      • Beaucouze, France
        • 1235.7.3309A Boehringer Ingelheim Investigational Site
      • Bourg des cptes, France
        • 1235.7.3305A Boehringer Ingelheim Investigational Site
      • Briollay, France
        • 1235.7.3306D Boehringer Ingelheim Investigational Site
      • Cholet, France
        • 1235.7.3308B Boehringer Ingelheim Investigational Site
      • Cholet, France
        • 1235.7.3308F Boehringer Ingelheim Investigational Site
      • Garchizy, France
        • 1235.7.3302C Boehringer Ingelheim Investigational Site
      • Grandchamps, France
        • 1235.7.3303C Boehringer Ingelheim Investigational Site
      • Guerigny, France
        • 1235.7.3302D Boehringer Ingelheim Investigational Site
      • Jarny, France
        • 1235.7.3310A Boehringer Ingelheim Investigational Site
      • La Chapelle /s Erdre, France
        • 1235.7.3301L Boehringer Ingelheim Investigational Site
      • La Chapelle sur Erdre, France
        • 1235.7.3301J Boehringer Ingelheim Investigational Site
      • La Fresnais, France
        • 1235.7.3304A Boehringer Ingelheim Investigational Site
      • La Jubaudière, France
        • 1235.7.3308E Boehringer Ingelheim Investigational Site
      • La Montagne, France
        • 1235.7.3301G Boehringer Ingelheim Investigational Site
      • Le Mesnil en Vallée, France
        • 1235.7.3307D Boehringer Ingelheim Investigational Site
      • Le Temple de Bretagne, France
        • 1235.7.3301E Boehringer Ingelheim Investigational Site
      • Les Ponts de CE, France
        • 1235.7.3309F Boehringer Ingelheim Investigational Site
      • Louvigné le Bais, France
        • 1235.7.3305B Boehringer Ingelheim Investigational Site
      • Mouliherne, France
        • 1235.7.3307E Boehringer Ingelheim Investigational Site
      • Murs Erigne, France
        • 1235.7.3306A Boehringer Ingelheim Investigational Site
      • Murs-Erigne, France
        • 1235.7.3307A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1235.7.3301A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1235.7.3301B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1235.7.3301D Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1235.7.3301M Boehringer Ingelheim Investigational Site
      • Nevers, France
        • 1235.7.3302A Boehringer Ingelheim Investigational Site
      • Nevers, France
        • 1235.7.3302F Boehringer Ingelheim Investigational Site
      • Nort sur Erdre, France
        • 1235.7.3301I Boehringer Ingelheim Investigational Site
      • Orvault, France
        • 1235.7.3301C Boehringer Ingelheim Investigational Site
      • Parcay les Pins, France
        • 1235.7.3307F Boehringer Ingelheim Investigational Site
      • Sautron, France
        • 1235.7.3301N Boehringer Ingelheim Investigational Site
      • Segre, France
        • 1235.7.3306B Boehringer Ingelheim Investigational Site
      • St Aubin les Châteaux, France
        • 1235.7.3301F Boehringer Ingelheim Investigational Site
      • St Georges de Montaigu, France
        • 1235.7.3306F Boehringer Ingelheim Investigational Site
      • St Ouen La Rouerie, France
        • 1235.7.3304B Boehringer Ingelheim Investigational Site
      • Thouars, France
        • 1235.7.3306E Boehringer Ingelheim Investigational Site
      • Tinténiac, France
        • 1235.7.3304C Boehringer Ingelheim Investigational Site
      • Vihiers, France
        • 1235.7.3308A Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • 1235.7.82007 Boehringer Ingelheim Investigational Site
      • Daegu, Korea, Republic of
        • 1235.7.82001 Boehringer Ingelheim Investigational Site
      • Daejon, Korea, Republic of
        • 1235.7.82006 Boehringer Ingelheim Investigational Site
      • Gangwon-Do, Korea, Republic of
        • 1235.7.82004 Boehringer Ingelheim Investigational Site
      • Gwangju, Korea, Republic of
        • 1235.7.82008 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1235.7.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1235.7.82003 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1235.7.82005 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Beerzerveld, Netherlands
        • 1235.7.31008 Boehringer Ingelheim Investigational Site
      • Bennebroek, Netherlands
        • 1235.7.31006 Boehringer Ingelheim Investigational Site
      • Hoogwoud, Netherlands
        • 1235.7.31004 Boehringer Ingelheim Investigational Site
      • Musselkanaal, Netherlands
        • 1235.7.31003 Boehringer Ingelheim Investigational Site
      • Nijverdal, Netherlands
        • 1235.7.31007 Boehringer Ingelheim Investigational Site
      • Oude Pekela, Netherlands
        • 1235.7.31001 Boehringer Ingelheim Investigational Site
      • Roelofarendsveen, Netherlands
        • 1235.7.31005 Boehringer Ingelheim Investigational Site
      • Voerendaal, Netherlands
        • 1235.7.31010 Boehringer Ingelheim Investigational Site
  • Norway
      • Bergen, Norway
        • 1235.7.47002 Boehringer Ingelheim Investigational Site
      • Hamar, Norway
        • 1235.7.47003 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 1235.7.47004 Boehringer Ingelheim Investigational Site
      • Ålesund, Norway
        • 1235.7.47001 Boehringer Ingelheim Investigational Site
  • Philippines
      • Makati City, Philippines
        • 1235.7.63006 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1235.7.63001 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1235.7.63002 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1235.7.63009 Boehringer Ingelheim Investigational Site
      • Pasay City, Philippines
        • 1235.7.63008 Boehringer Ingelheim Investigational Site
      • Pasig City, Philippines
        • 1235.7.63005 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1235.7.63003 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1235.7.63007 Boehringer Ingelheim Investigational Site
  • South Africa
      • Boksburg, South Africa
        • 1235.7.27003 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 1235.7.27006 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 1235.7.27009 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 1235.7.27010 Boehringer Ingelheim Investigational Site
      • Durban, South Africa
        • 1235.7.27004 Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa
        • 1235.7.27007 Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa
        • 1235.7.27008 Boehringer Ingelheim Investigational Site
      • Krugersdorp, South Africa
        • 1235.7.27001 Boehringer Ingelheim Investigational Site
      • Lenasia, South Africa
        • 1235.7.27005 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 1235.7.27002 Boehringer Ingelheim Investigational Site
  • Sweden
      • Göteborg, Sweden
        • 1235.7.46002 Boehringer Ingelheim Investigational Site
      • Göteborg, Sweden
        • 1235.7.46003 Boehringer Ingelheim Investigational Site
      • Luleå, Sweden
        • 1235.7.46005 Boehringer Ingelheim Investigational Site
      • Rättvik, Sweden
        • 1235.7.46004 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1235.7.46001 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Changhua, Taiwan
        • 1235.7.88605 Boehringer Ingelheim Investigational Site
      • Hualien City, Taiwan
        • 1235.7.88608 Boehringer Ingelheim Investigational Site
      • Kaohsiung, Taiwan
        • 1235.7.88601 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1235.7.88603 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
  2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
  3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

Exclusion Criteria:

  1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study
  2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
  3. discontinuation from the preceding trial because of any adverse event or any other reason
  4. known or suspected secondary hypertension
  5. mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Seated Diastolic Blood Pressure (DBP) Control
Time Frame: End of study (34 weeks or last value on treatment)
The number of patients who reach the target DBP of <90mmHg
End of study (34 weeks or last value on treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Seated DBP Response
Time Frame: End of study (34 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 (34 weeks or last value on treatment)
Trough Seated SBP Response
Time Frame: End of study (34 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 (34 weeks or last value on treatment)
Trough Seated Systolic Blood Pressure (SBP) Control
Time Frame: End of study (34 weeks or last value on treatment)
The number of patients who reach the target SBP of <140mmHg
End of study (34 weeks or last value on treatment)
Change From Baseline in Trough Seated Diastolic Blood Pressure
Time Frame: End of study (34 weeks or last value on treatment)
Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.
End of study (34 weeks or last value on treatment)
Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
Time Frame: End of study (34 weeks or last value on treatment)
The difference between the last available troughs represents the additional reduction in DBP in this study
End of study (34 weeks or last value on treatment)
Change From Baseline in Trough Seated Systolic Blood Pressure
Time Frame: End of study (34 weeks or last value on treatment)
Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.
End of study (34 weeks or last value on treatment)
Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
Time Frame: End of study (34 weeks or last value on treatment)
The difference between the last available troughs represents the additional reduction in SBP in this study
End of study (34 weeks or last value on treatment)
Trough Blood Pressure (BP) Normality Classes
Time Frame: End of study (34 weeks or last value on treatment)
The number of patients who reach predefined BP categories
End of study (34 weeks or last value on treatment)
Time to First Additional Antihypertensive
Time Frame: At any point during open-label treatment
Time from first intake of medication to first intake of an antihypertensive other than the study drug
At any point during open-label treatment
Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Time Frame: At any point during open-label treatment
The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
At any point during open-label treatment
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Time Frame: At any point during open-label treatment
Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7
At any point during open-label treatment
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Time Frame: At any point during open-label treatment
Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7
At any point during open-label treatment
Trough DBP Control Pre- and Post- Uptitration
Time Frame: At any point during open-label treatment
The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration
At any point during open-label 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.

General Publications

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

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

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

  • 1235.7
  • EUDRACT2007-002410-19

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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