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26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
This study has been completed.
First Received: February 5, 2008   Last Updated: July 23, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00624052
  Purpose

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations T40/A10 or 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 diastolic blood pressure (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).


Condition Intervention Phase
Hypertension
Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg
Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg
Phase III

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients achieving diastolic blood pressure control [ Time Frame: six months ]

Secondary Outcome Measures:
  • Change from baseline in seated blood pressure [ Time Frame: six months ]

Enrollment: 838
Study Start Date: March 2008
Primary Completion Date: June 2009 (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

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 T40/A10 or T80/A10.
  • discontinuation from the preceding trial.
  • known or suspected secondary hypertension.
  • mean seated SBP >= 180 mmHg and/or mean seated 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 ACE inhibitors or 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624052

  Show 92 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: 1235.8, EUDRACT 2007-002422-29
Study First Received: February 5, 2008
Last Updated: July 23, 2009
ClinicalTrials.gov Identifier: NCT00624052     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 prov. 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 (AEMPS);   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

Study placed in the following topic categories:
Anti-Infective Agents
Vasodilator Agents
Benzoates
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Protease Inhibitors
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Antifungal Agents
Angiotensin-Converting Enzyme Inhibitors
Telmisartan
Hypertension

Additional relevant MeSH terms:
Anti-Infective Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Benzoates
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Antifungal Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on September 04, 2009