Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00553267
First received: October 8, 2007
Last updated: December 16, 2013
Last verified: December 2013

October 8, 2007
December 16, 2013
November 2007
October 2008   (final data collection date for primary outcome measure)
Change From Baseline in Trough Seated Diastolic Blood Pressure [ Time Frame: Baseline and end of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
Change from baseline to the end of study in trough DBP
Change from baseline in seated trough DBP after 8 weeks of randomised treatment
Complete list of historical versions of study NCT00553267 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Trough Seated Systolic Blood Pressure [ Time Frame: Baseline and end of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    Change from baseline to the end of study in trough SBP
  • Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target DBP of <90mmHg
  • Trough Seated Diastolic Blood Pressure <80 mmHg [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target DBP of <80mmHg
  • Trough Seated DBP Response [ Time Frame: End of study (8 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 Control [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach the target SBP of <140mmHg
  • Trough Seated SBP Response [ Time Frame: End of study (8 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 Seated BP Normality Classes [ Time Frame: End of study (8 weeks or last value on treatment) ] [ Designated as safety issue: No ]
    The number of patients who reach predefined BP categories
  • Oedema Incidence Rate [ Time Frame: During randomised treatment period ] [ Designated as safety issue: No ]
    The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)
  • Peripheral Oedema Incidence Rate [ Time Frame: During randomised treatment period ] [ Designated as safety issue: No ]
    The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)
Change from baseline in seated SBP at 8 weeks. Proportion of patients achieving DBP control, DBP response, SBP response and proportion having optimal BP, normal BP, high/normal BP and high BP at 8 weeks. Safety and tolerabilty.
Not Provided
Not Provided
 
Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy

The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Hypertension
  • Drug: fixed dose combination of telmisartan+amlodipine
  • Drug: amlodipine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
947
Not Provided
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg if treatment-naïve).
  • failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP >= 90 mmHg.)
  • able to stop any current antihypertensive therapy without unacceptable risk to the patient.
  • willing and able to provide written informed consent.

Exclusion Criteria:

  • pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
  • known or suspected secondary hypertension.
  • mean seated systolic blood pressure (SBP) >=200 mmHg and/or mean seated DBP >= 120 mmHg during run-in treatment or mean seated SBP >= 180 mmHg and/or mean seated DBP >= 120 mmHg at the randomisation visit or at any time during randomised treatment.
  • 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 ACE inhibitors or ARBs.
  • history of drug or alcohol dependency within the six months prior to signing consent.
  • concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent.
  • 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 CCBs.)
  • non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period.
  • current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period.
  • chronic administration of any medication known to affect blood pressure, other than the 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Bulgaria,   Czech Republic,   Ireland,   Italy,   New Zealand,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Turkey,   Ukraine,   United Kingdom
 
NCT00553267
1235.6, EUDRACT 2007-002421-68
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2013

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