Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 5, 2008
First Posted Date  ICMJE February 26, 2008
Results First Submitted Date  ICMJE December 28, 2009
Results First Posted Date  ICMJE March 25, 2010
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00624052 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
Official Title  ICMJE 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
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg
  • Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg
Study Arms  ICMJE Not Provided
Publications * Neldam S, Edwards C, Lang M, Jones R; TEAMSTA-5 and TEAMSTA-10 Investigators. Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and TEAMSTA-10 Studies. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):65-84. doi: 10.1016/j.curtheres.2012.02.004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2009)
838
Original Enrollment  ICMJE
 (submitted: February 25, 2008)
680
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Bulgaria,   Czech Republic,   Ireland,   Italy,   New Zealand,   Russian Federation,   Slovakia,   Spain,   Ukraine,   United Kingdom
Removed Location Countries Switzerland,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT00624052
Other Study ID Numbers  ICMJE 1235.8
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP