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

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ClinicalTrials.gov Identifier: NCT00624052
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : March 25, 2010
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Hypertension Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 838 participants
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624052


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00624052     History of Changes
Other Study ID Numbers: 1235.8
First Posted: February 26, 2008    Key Record Dates
Results First Posted: March 25, 2010
Last Update Posted: May 20, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists