26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

May 13, 2014 updated by: Boehringer Ingelheim

An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg 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 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

838

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
        • 1235.8.61003 Boehringer Ingelheim Investigational Site
      • Liverpool, New South Wales, Australia
        • 1235.8.61004 Boehringer Ingelheim Investigational Site
    • Queensland
      • Kippa-Ring, Queensland, Australia
        • 1235.8.61002 Boehringer Ingelheim Investigational Site
      • Milton, Queensland, Australia
        • 1235.8.61001 Boehringer Ingelheim Investigational Site
    • South Australia
      • Elizabeth Vale, South Australia, Australia
        • 1235.8.61005 Boehringer Ingelheim Investigational Site
  • Austria
      • Eggenburg, Austria
        • 1235.8.43007 Boehringer Ingelheim Investigational Site
      • Hainburg a.d. Donau, Austria
        • 1235.8.43006 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1235.8.43001 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1235.8.43002 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 1235.8.43003 Boehringer Ingelheim Investigational Site
  • Bulgaria
      • Bourgas, Bulgaria
        • 1235.8.35912 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.8.35902 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.8.35903 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.8.35904 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.8.35905 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.8.35906 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.8.35907 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.8.35910 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 1235.8.35911 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Benatky nad Jizerou, Czech Republic
        • 1235.8.42002 Boehringer Ingelheim Investigational Site
      • Brno, Czech Republic
        • 1235.8.42006 Boehringer Ingelheim Investigational Site
      • Plzen, Czech Republic
        • 1235.8.42001 Boehringer Ingelheim Investigational Site
      • Praha 5, Czech Republic
        • 1235.8.42003 Boehringer Ingelheim Investigational Site
      • Pribram, Czech Republic
        • 1235.8.42004 Boehringer Ingelheim Investigational Site
      • Slany, Czech Republic
        • 1235.8.42005 Boehringer Ingelheim Investigational Site
      • Strakonice, Czech Republic
        • 1235.8.42007 Boehringer Ingelheim Investigational Site
  • Ireland
      • Birr, Ireland
        • 1235.8.35304 Boehringer Ingelheim Investigational Site
      • Carrigtowhill, Ireland
        • 1235.8.35305 Boehringer Ingelheim Investigational Site
      • Gorey, Co. Wexford, Ireland
        • 1235.8.35303 Boehringer Ingelheim Investigational Site
      • Mallow, Ireland
        • 1235.8.35306 Boehringer Ingelheim Investigational Site
      • New Ross, Ireland
        • 1235.8.35301 Boehringer Ingelheim Investigational Site
  • Italy
      • Broni (pv), Italy
        • 1235.8.39002 Boehringer Ingelheim Investigational Site
      • Coppito (AQ), Italy
        • 1235.8.39006 Boehringer Ingelheim Investigational Site
      • Ferrara, Italy
        • 1235.8.39001 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Dunedin, New Zealand
        • 1235.8.64003 Boehringer Ingelheim Investigational Site
      • Otahuhu, Auckland, New Zealand
        • 1235.8.64002 Boehringer Ingelheim Investigational Site
      • Tauranga, New Zealand
        • 1235.8.64001 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1235.8.70004 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.8.70005 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.8.70006 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.8.70007 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.8.70008 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1235.8.70009 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.8.70010 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.8.70011 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1235.8.70012 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Dolny Kubin, Slovakia
        • 1235.8.42103 Boehringer Ingelheim Investigational Site
      • Kralovsky Chmlec, Slovakia
        • 1235.8.42106 Boehringer Ingelheim Investigational Site
      • Liptovsky Mikulas, Slovakia
        • 1235.8.42104 Boehringer Ingelheim Investigational Site
      • Povazska Bystrica, Slovakia
        • 1235.8.42102 Boehringer Ingelheim Investigational Site
      • Presov, Slovakia
        • 1235.8.42105 Boehringer Ingelheim Investigational Site
      • Trencin, Slovakia
        • 1235.8.42101 Boehringer Ingelheim Investigational Site
      • Vrable, Slovakia
        • 1235.8.42107 Boehringer Ingelheim Investigational Site
  • Spain
      • Badalona, Spain
        • 1235.8.34008 Boehringer Ingelheim Investigational Site
      • Badalona, Spain
        • 1235.8.34010 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1235.8.34009 Boehringer Ingelheim Investigational Site
      • Jerez de la Frontera (Cádiz), Spain
        • 1235.8.34001 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat (Barcelona), Spain
        • 1235.8.34006 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1235.8.34003 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1235.8.34004 Boehringer Ingelheim Investigational Site
      • Mataró, Spain
        • 1235.8.34012 Boehringer Ingelheim Investigational Site
      • Oviedo, Spain
        • 1235.8.34002 Boehringer Ingelheim Investigational Site
      • Santa Coloma de Gramanet, Spain
        • 1235.8.34005 Boehringer Ingelheim Investigational Site
      • Santa Coloma de Gramanet, Spain
        • 1235.8.34011 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • 1235.8.38010 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.8.38001 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.8.38003 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.8.38008 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1235.8.38011 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.8.38004 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.8.38006 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.8.38012 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1235.8.38013 Boehringer Ingelheim Investigational Site
      • Lvov, Ukraine
        • 1235.8.38002 Boehringer Ingelheim Investigational Site
      • Odessa, Ukraine
        • 1235.8.38005 Boehringer Ingelheim Investigational Site
      • Odessa, Ukraine
        • 1235.8.38009 Boehringer Ingelheim Investigational Site
      • Zaporozhye, Ukraine
        • 1235.8.38007 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Bexhill on Sea, United Kingdom
        • 1235.8.44010 Boehringer Ingelheim Investigational Site
      • Blackpool, United Kingdom
        • 1235.8.44008 Boehringer Ingelheim Investigational Site
      • Blackpool, United Kingdom
        • 1235.8.44016 Boehringer Ingelheim Investigational Site
      • Burbage, United Kingdom
        • 1235.8.44011 Boehringer Ingelheim Investigational Site
      • Chestfield, Whitstable, United Kingdom
        • 1235.8.44007 Boehringer Ingelheim Investigational Site
      • Chorley, United Kingdom
        • 1235.8.44005 Boehringer Ingelheim Investigational Site
      • Edgbaston, Birmingham, United Kingdom
        • 1235.8.44002 Boehringer Ingelheim Investigational Site
      • Ely, United Kingdom
        • 1235.8.44009 Boehringer Ingelheim Investigational Site
      • Fowey, United Kingdom
        • 1235.8.44001 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 1235.8.44003 Boehringer Ingelheim Investigational Site
      • Penzance, United Kingdom
        • 1235.8.44012 Boehringer Ingelheim Investigational Site
      • Plymouth, United Kingdom
        • 1235.8.44013 Boehringer Ingelheim Investigational Site
      • Reading, United Kingdom
        • 1235.8.44004 Boehringer Ingelheim Investigational Site
      • St. Austell, United Kingdom
        • 1235.8.44015 Boehringer Ingelheim Investigational Site
      • Whitstable, United Kingdom
        • 1235.8.44006 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

Exclusion Criteria:

  • pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
  • development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
  • discontinuation from the preceding trial.
  • known or suspected secondary hypertension.
  • mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic blood pressure (DBP) >= 120 mmHg at any visit.
  • 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 angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
  • any new drug or alcohol dependency since signing consent of the preceding trial.
  • concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
  • 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 calcium channel blockers (CCBs).] non-compliance with study medication (defined as <80% or >120%) during the preceding trial.
  • administration of ARBs or dihydropyridine CCBs (apart from 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

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 reached 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 Systolic Blood Pressure (SBP) Control
Time Frame: End of study (34 weeks or last value on treatment)
The number of patients who reached the target SBP of >=140mmHg
End of study (34 weeks or last value on treatment)
Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure
Time Frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 1235.6
Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Time Frame: Last available trough in NCT00553267 to 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
Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)
Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure
Time Frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 1235.6
Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Time Frame: Last available trough in NCT00624052 to 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
Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)
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 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: up to 34 weeks
Time from first intake of medication to first intake of an antihypertensive other than the study drug
up to 34 weeks
Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Time Frame: up to 34 weeks
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
up to 34 weeks
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Time Frame: up to 34 weeks
Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052
up to 34 weeks
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Time Frame: up to 34 weeks
Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052
up to 34 weeks
Trough DBP Control Pre- and Post- Uptitration
Time Frame: up to 34 weeks
The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.
up to 34 weeks

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

March 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1235.8

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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