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

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 - Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for 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
Status
LocationsStatus
Locations

A.O. San Gerardo di Monza

Monza, Italy, 20052

Status
Completed
 
Locations

A.O.U. di Bologna

Bologna, Italy, 40138

Status
Completed
 
Locations

A.O. Spedali Civili

Brescia, Italy, 25123

Status
Completed
 
Locations

A.O.U. di Ferrara

Ferrara, Italy, 44100

Status
Completed
 
Locations

IRCCS Ist Auxologico Italiano

Milano, Italy, 20143

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

A.O.U. Ospedali Riuniti Trieste

Trieste, Italy, 34149

Status
Completed
 
Locations

A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

Status
Completed
 
Locations

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

Ancona, Italy, 60126

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

ASL RM/B Roma - Lazio

Roma, Italy, 00157

Status
Completed
 
Locations

ARNAS Garibaldi

Catania, Italy, 95126

Status
Completed
 
Locations

A.O.U. di Sassari

Sassari, Italy, 07100

Status
Completed
 
Locations

AULSS 09 Treviso - Veneto

Treviso, Italy, 31100

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Hospital SAS de Jerez

Jerez de la Frontera, Spain, 11407

Status
Completed
 
Locations

Hospital Regional Carlos Haya

Málaga, Spain, 29010

Status
Completed
 
Locations

Centro de Salud Ingeniero Joaquín Benlloch

Valencia, Spain, 46006

Status
Completed
 
Locations

ASL Prov Pavia - Lombardia

Broni, Italy, 27043

Status
Completed
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

A.O. Sant'Antonio Abate

Somma Lombardo, Italy, 21013

Status
Completed
 
Locations

AUSL 4 L'Aquila - Abruzzo

L'Aquila, Italy, 67100

Status
Completed
 
Locations

A.O. di Perugia

Perugia, Italy, 06129

Status
Completed
 
Locations

A.O. San Camillo-Forlanini

Roma, Italy, 00152

Status
Completed
 
Locations

Azienda Policlinico Umberto I

Roma, Italy, 00161

Status
Completed
 
Locations

A.O.U. Policlinico Paolo Giaccone

Palermo, Italy, 90127

Status
Completed
 
Locations

IRCCS Ist Neurologico Mediterraneo

Pozzilli, Italy, 86077

Status
Completed
 
Locations

A.O. Umberto I di Siracusa

Siracusa, Italy, 96100

Status
Completed
 
Locations

Università di Pavia

Pavia, Italy, 27100

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Hospital Dr. Negrín

Las Palmas de Gran Canaria, Spain, 35020

Status
Completed
 
Locations

Complexo Hospitalario Universitario de Ferrol

Ferrol, Spain, 15405

Status
Completed
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Completed
 
Locations

Ospedale Bassini

Cinisello Balsamo, Italy, 20092

Status
Terminated
 
Locations

A.O.U. Maggiore della Carità

Novara, Italy, 28100

Status
Terminated
 
Locations

AULSS 12 Veneziana - Veneto

Venezia, Italy, 30122

Status
Terminated
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Terminated
 
Locations

ASL NA 1 Napoli - Campania

Napoli, Italy, 80136

Status
Terminated
 
Locations

ASL NA 1 Napoli - Campania

Napoli, Italy, 80141

Status
Terminated
 
Locations

Hospital Universitario Infanta Cristina de Badajoz

Badajoz, Spain, 06080

Status
Terminated
 
Locations

Hospital General de Ciudad Real

Ciudad Real, Spain, 13005

Status
Terminated
 
Locations

Hospital de Cabueñes

Gijón, Spain, 33394

Status
Terminated
 
Locations

Centro de Salud Beniganim

Beniganim, Spain, 46830

Status
Terminated
 

Trial Design