Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.
NCT ID: NCT00750113
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
405 participants
INTERVENTIONAL
2007-10-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Nifidipine
Tablets 20 Mg daily for 4 weeks then combination therapy
Arm 2
Telmisartan
Tablets 80 Mg daily for 4 weeks then combination therapy
Arm 3
Nifedipine/Telmisartan
2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning
Interventions
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Nifidipine
Tablets 20 Mg daily for 4 weeks then combination therapy
Telmisartan
Tablets 80 Mg daily for 4 weeks then combination therapy
Nifedipine/Telmisartan
2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning
Eligibility Criteria
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Inclusion Criteria
* Presence of type 2 diabetes mellitus or target organ damage (echocardiographic or electrocardiographic left ventricular hypertrophy or microalbuminuria)
* Presence of a metabolic syndrome, i.e at least two of the following \[(from letter (a) to letter(d)\] in patients with organ damage or at least one of the following \[from letter (b) to letter (d)\] in patients with diabetes mellitus: (a) impaired glucose tolerance (fasting plasma glucose 110 -125 mg/dl) (b )raised serum triglycerides (\>/= 150 mg/dl) or comitant use of statins for this indication(c) low HDL cholesterol (males: \< 40 mg/dl, females: \< 50 mg/dl)(d) waist circumference \>102 cm in men and \>88 cm in women
* Age: 18-75 years
* Negative pregnancy test in females
* Written informed consent
Exclusion Criteria
* Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for \>/= 4 week) and that won't possibly be kept stable over the whole duration of the study.
* Concomitant treatment with known cytochrome P450-3A4 inhibitors (e.g cimetidine, anti-HIV protease inhibitors e.g. ritonavir, azole anti-mycotics eg. Ketoconazole, digoxin, quinidine, tacrolimus) or inducers such as anti-epileptic drugs (eg. phenytoin, carbamazepine and phenobarbitone) or rifampicin
* Concomitant treatment with potassium sparingdiuretics.
* Malignant, severe or labile essential hypertension, orthostatic hypotension
* Cardiovascular shock
* Evidence of secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis or pheochromocytoma
* Myocardial infarction or unstable angina within the previous 12 months
* Severe cardiac valve disease
* Severe rhythm or conduction disorder:
* Cerebrovascular ischaemic event (stroke, transient ischaemic attack) within the previous 12 months
* History of intra-cerebral haemorrhage or sub-arachnoid haemorrhage within the previous 12 months
* Type 1 diabetes mellitus
* Proteinuria (determined by uristix)
* BMI \> 34
* Uncorrected hypokalemia or hyperkalemia, potassium outside the range 3.0 to 5.5 mmol/l
* Sodium depletion and/or hypovolemia
* Gastrointestinal disease resulting in the potential for malabsorption)
* Liver disease or transaminase (AST, ALT) levels \> 3 x the upper limit of normal range.
* Renal failure, creatinine \>2.0 mg/dl
18 Years
75 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Pozzilli, Isernia, Italy
Monza, Monza-Brianza, Italy
Somma Lombardo, Varese, Italy
Ancona, , Italy
Bologna, , Italy
Brescia, , Italy
Broni, , Italy
Catania, , Italy
Cinisello Balsamo, , Italy
Ferrara, , Italy
L’Aquila, , Italy
Milan, , Italy
Napoli, , Italy
Napoli, , Italy
Novara, , Italy
Padua, , Italy
Palermo, , Italy
Pavia, , Italy
Perugia, , Italy
Pisa, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Sassari, , Italy
Siena, , Italy
Syracuse, , Italy
Treviso, , Italy
Trieste, , Italy
Varese, , Italy
Venezia, , Italy
Ferrol, A Coruña, Spain
Badajoz, Badajoz, Spain
Badalona, Barcelona, Spain
Ciudad Real, Ciudad Real, Spain
Jerez de la Frontera, Cádiz, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Málaga, Spain
Gijón, Principality of Asturias, Spain
Benigànim, Valencia, Spain
Valencia, Valencia, Spain
Countries
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References
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Mancia G, Parati G, Bilo G, Choi J, Kilama MO, Ruilope LM; TALENT investigators. Blood pressure control by the nifedipine GITS-telmisartan combination in patients at high cardiovascular risk: the TALENT study. J Hypertens. 2011 Mar;29(3):600-9. doi: 10.1097/HJH.0b013e328342ef04.
Related Links
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Click here and search for Bayer Product infromation provided by EMA
Other Identifiers
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2006-006436-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12313
Identifier Type: -
Identifier Source: org_study_id