Trial Condition(s):

Hypertension

Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.

Bayer Identifier:

12313

ClinicalTrials.gov Identifier:

NCT00750113

EudraCT Number:

2006-006436-22

EU CT Number:

Not Available

Study Completed

Trial Purpose

Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing cardiovascular events such as myocardial infarction or stroke. To reduce this risk an appropriate antihypertensive therapy should allow to reach a target blood pressure of less than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is to evaluate the efficacy in blood pressure control when anti-hypertensive therapy is initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a regimen starting with monotherapy before adding the other drug.The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) at 16 weeks of treatment compared to baseline

Inclusion Criteria
- Hypertension (office systolic blood pressure > 135 mmHg), untreated or poorly controlled but stable antihypertensive regimen for >/= 4 weeks
 - 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 AT1-antagonists e.g. losartan, eprosartan, telmisartan) or calcium-antagonists (e.g. amlodipine, felodipine,  isradipine, nifedipine, nimodipine).
 - Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for 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
 - General  Exclusion Criteria: any malignant  disease that has required treatment within the last five years, dementia or psychosis, history of non-compliance, alcoholism or drug abuse, treatment with any other investigational drug in the 30 days prior to entering the study, pregnancy and lactation, known state of allergy or hypersensitivity to nifedipine or any other dihydropyridine or to telmisartan, any surgical or  medical condition which at the discretion of the investigator place the subject at higher risk from his/her participation in the study or are likely to prevent the subject from complying with the requirements of the study or completing the trial period, history of non compliance to medical regimens or subjects unwilling to comply with the study protocol.

Trial Summary

Enrollment Goal
405
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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A.O. San Gerardo di Monza

Monza, Italy, 20052

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A.O.U. di Bologna

Bologna, Italy, 40138

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A.O. Spedali Civili

Brescia, Italy, 25123

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A.O.U. di Ferrara

Ferrara, Italy, 44100

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IRCCS Ist Auxologico Italiano

Milano, Italy, 20143

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A.O. di Padova

Padova, Italy, 35128

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A.O.U. Ospedali Riuniti Trieste

Trieste, Italy, 34149

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A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

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A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi

Ancona, Italy, 60126

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A.O.U. Pisana

Pisa, Italy, 56126

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ASL RM/B Roma - Lazio

Roma, Italy, 00157

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ARNAS Garibaldi

Catania, Italy, 95126

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A.O.U. di Sassari

Sassari, Italy, 07100

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AULSS 09 Treviso - Veneto

Treviso, Italy, 31100

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Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

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Hospital SAS de Jerez

Jerez de la Frontera, Spain, 11407

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Hospital Regional Carlos Haya

Málaga, Spain, 29010

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Centro de Salud Ingeniero Joaquín Benlloch

Valencia, Spain, 46006

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ASL Prov Pavia - Lombardia

Broni, Italy, 27043

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IRCCS Policlinico San Matteo

Pavia, Italy, 27100

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A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

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A.O. Sant'Antonio Abate

Somma Lombardo, Italy, 21013

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AUSL 4 L'Aquila - Abruzzo

L'Aquila, Italy, 67100

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A.O. di Perugia

Perugia, Italy, 06129

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A.O. San Camillo-Forlanini

Roma, Italy, 00152

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Azienda Policlinico Umberto I

Roma, Italy, 00161

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A.O.U. Policlinico Paolo Giaccone

Palermo, Italy, 90127

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IRCCS Ist Neurologico Mediterraneo

Pozzilli, Italy, 86077

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A.O. Umberto I di Siracusa

Siracusa, Italy, 96100

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Università di Pavia

Pavia, Italy, 27100

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Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

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Hospital Dr. Negrín

Las Palmas de Gran Canaria, Spain, 35020

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Complexo Hospitalario Universitario de Ferrol

Ferrol, Spain, 15405

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Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

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Ospedale Bassini

Cinisello Balsamo, Italy, 20092

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A.O.U. Maggiore della Carità

Novara, Italy, 28100

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AULSS 12 Veneziana - Veneto

Venezia, Italy, 30122

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A.O.U. Senese

Siena, Italy, 53100

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ASL NA 1 Napoli - Campania

Napoli, Italy, 80136

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ASL NA 1 Napoli - Campania

Napoli, Italy, 80141

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Hospital Universitario Infanta Cristina de Badajoz

Badajoz, Spain, 06080

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Hospital General de Ciudad Real

Ciudad Real, Spain, 13005

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Hospital de Cabueñes

Gijón, Spain, 33394

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Centro de Salud Beniganim

Beniganim, Spain, 46830

Trial Design