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Клинические исследования в Украине

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Описание
Краткое название26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
Полное названиеAn 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
СпонсорBoehringer Ingelheim Pharmaceuticals
Industry
ИсточникBoehringer Ingelheim Pharmaceuticals
Под контролемAustralia: 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 Espa?±ola del Medicamento y Productos Sanitarios (AEMPS)
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
Краткое описаниеThe primary objective of this trial is to assess the efficacy and safety of the fixed dose
combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg
(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 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).
СостояниеЗавершено
Дата началаMarch 2008
ФазаPhase 3
Вид исследованияEndpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Набор0
КритерииInclusion 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
telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg
(T80/A10).

- discontinuation from the preceding trial.

- known or suspected secondary hypertension.

- mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic
blood pressure (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 angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor
blockers (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 calcium channel blockers (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.
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеHypertension
Применяемое лечение
Drugfixed-dose combination of telmisartan 40mg+amlodipine 10mg
Drugfixed-dose combination of telmisartan 80mg+amlodipine10mg
Контакты и расположение
Dnepropetrovsk 1235.8.38010 Boehringer Ingelheim Investigational Site
Kharkov 1235.8.38001 Boehringer Ingelheim Investigational Site
Kharkov 1235.8.38003 Boehringer Ingelheim Investigational Site
Kharkov 1235.8.38011 Boehringer Ingelheim Investigational Site
Kharkov 1235.8.38008 Boehringer Ingelheim Investigational Site
Kiev 1235.8.38006 Boehringer Ingelheim Investigational Site
Kiev 1235.8.38004 Boehringer Ingelheim Investigational Site
Kiev 1235.8.38012 Boehringer Ingelheim Investigational Site
Kiev 1235.8.38013 Boehringer Ingelheim Investigational Site
Lvov 1235.8.38002 Boehringer Ingelheim Investigational Site
Odessa 1235.8.38005 Boehringer Ingelheim Investigational Site
Odessa 1235.8.38009 Boehringer Ingelheim Investigational Site
Zaporozhye 1235.8.38007 Boehringer Ingelheim Investigational Site
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