Trial Condition(s):
Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.
12313
Not Available
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
- 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
- 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 - Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for 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.
Locations | Status | |
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Locations A.O. San Gerardo di Monza Monza, Italy, 20052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Spedali Civili Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Ferrara Ferrara, Italy, 44100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Auxologico Italiano Milano, Italy, 20143 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Trieste Trieste, Italy, 34149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp Circolo e Fond.Macchi Varese, Italy, 21100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi Ancona, Italy, 60126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL RM/B Roma - Lazio Roma, Italy, 00157 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ARNAS Garibaldi Catania, Italy, 95126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Sassari Sassari, Italy, 07100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 09 Treviso - Veneto Treviso, Italy, 31100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital SAS de Jerez Jerez de la Frontera, Spain, 11407 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional Carlos Haya Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Ingeniero Joaquín Benlloch Valencia, Spain, 46006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL Prov Pavia - Lombardia Broni, Italy, 27043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sant'Antonio Abate Somma Lombardo, Italy, 21013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 4 L'Aquila - Abruzzo L'Aquila, Italy, 67100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Perugia Perugia, Italy, 06129 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Camillo-Forlanini Roma, Italy, 00152 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Azienda Policlinico Umberto I Roma, Italy, 00161 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Paolo Giaccone Palermo, Italy, 90127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Neurologico Mediterraneo Pozzilli, Italy, 86077 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Umberto I di Siracusa Siracusa, Italy, 96100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università di Pavia Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Dr. Negrín Las Palmas de Gran Canaria, Spain, 35020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complexo Hospitalario Universitario de Ferrol Ferrol, Spain, 15405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Bassini Cinisello Balsamo, Italy, 20092 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Maggiore della Carità Novara, Italy, 28100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 12 Veneziana - Veneto Venezia, Italy, 30122 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Senese Siena, Italy, 53100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL NA 1 Napoli - Campania Napoli, Italy, 80136 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL NA 1 Napoli - Campania Napoli, Italy, 80141 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Infanta Cristina de Badajoz Badajoz, Spain, 06080 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General de Ciudad Real Ciudad Real, Spain, 13005 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Cabueñes Gijón, Spain, 33394 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Beniganim Beniganim, Spain, 46830 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
A Multicenter Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control and Beyond: comparison of two treatment strategies.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3