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Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
This study has been completed.
First Received: October 8, 2007   Last Updated: April 24, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00553267
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: fixed dose combination of telmisartan+amlodipine
Drug: amlodipine
Phase III

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in seated trough DBP after 8 weeks of randomised treatment [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 tolerability. [ Time Frame: 8 weeks ]

Enrollment: 949
Study Start Date: November 2007
Primary Completion Date: October 2008 (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 and blood pressure not adequately controlled before informed consent (inadequate control defined as seated 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553267

  Show 97 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1235.6, EUDRACT 2007-002421-68
Study First Received: October 8, 2007
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00553267     History of Changes
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 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:
Amlodipine
Telmisartan
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009