Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
This study has been completed.
Information provided by:
First received: October 8, 2007
Last updated: December 16, 2013
Last verified: December 2013
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.
Drug: fixed dose combination of telmisartan+amlodipine
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
- 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)
| Study Start Date:
| Primary Completion Date:
||October 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00553267
No publications provided
||Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
History of Changes
|Other Study ID Numbers:
||1235.6, EUDRACT 2007-002421-68
|Study First Received:
||October 8, 2007
|Results First Received:
||November 18, 2009
||December 16, 2013
||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 provinciale 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
Switzerland: Swissmedic, Hallerstrasse 7, 3000 Bern
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors