Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
This study has been completed.
Information provided by:
Boehringer Ingelheim Pharmaceuticals
First received: October 8, 2007
Last updated: May 18, 2012
Last verified: May 2012
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
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) ]
The number of patients who reach predefined BP categories
- Oedema Incidence Rate [ Time Frame: During randomised treatment period ]
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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553267
Boehringer Ingelheim Pharmaceuticals
||Boehringer Ingelheim Pharmaceuticals
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
||May 18, 2012
||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 December 05, 2013
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors