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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00624052
First received: February 5, 2008
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Hypertension
Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg
Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough Seated Diastolic Blood Pressure (DBP) Control [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reached the target DBP of <90mmHg


Secondary Outcome Measures:
  • Trough Seated Systolic Blood Pressure (SBP) Control [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reached the target SBP of >=140mmHg

  • 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 ] [ Designated as safety issue: No ]
    Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6

  • 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) ] [ Designated as safety issue: No ]
    The difference between the last available troughs represents the additional reduction in DBP in this study

  • 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 ] [ Designated as safety issue: No ]
    Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6

  • 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) ] [ Designated as safety issue: No ]
    The difference between the last available troughs represents the additional reduction in SBP in this study

  • Trough Seated DBP Response [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg

  • Trough Seated SBP Response [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg

  • Trough BP Normality Classes [ Time Frame: End of study (34 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach predefined BP categories

  • Time to First Additional Antihypertensive [ Time Frame: up to 34 weeks ] [ Designated as safety issue: No ]
    Time from first intake of medication to first intake of an antihypertensive other than the study drug

  • Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control [ Time Frame: up to 34 weeks ] [ Designated as safety issue: No ]
    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

  • Additional Reduction in DBP by Use of Additional Antihypertensive Therapy [ Time Frame: up to 34 weeks ] [ Designated as safety issue: No ]
    Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052

  • Additional Reduction in SBP by Use of Additional Antihypertensive Therapy [ Time Frame: up to 34 weeks ] [ Designated as safety issue: No ]
    Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052

  • Trough DBP Control Pre- and Post- Uptitration [ Time Frame: up to 34 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 838
Study Start Date: March 2008
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624052

  Show 92 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00624052     History of Changes
Other Study ID Numbers: 1235.8
Study First Received: February 5, 2008
Results First Received: December 28, 2009
Last Updated: May 13, 2014
Health Authority: Australia: Responsilble Ethics Committee
Austria: Federal Office for Safety in Health Care
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Great Britain: MHRA
Ireland: Irish Medicines Board
Italy: Comitato Etico della prov. Di Ferrara
New Zealand: Multicentre Ethics Committee/Medsafe
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS)
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Amlodipine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 14, 2014