check_circleStudy Completed

Hypertension

Bayer Identifier:

12313

ClinicalTrials.gov Identifier:

NCT00750113

EudraCT Number:

2006-006436-22

EU CT Number:

Not Available
Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.

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

Key Participants Requirements

Sex

Both

Age

18 - 75 Years
  • - 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    - Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for 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

Trial summary

Enrollment Goal
405
Trial Dates
October 2007 - August 2009
Phase
Phase 4
Could I Receive a placebo
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
A.O. San Gerardo di MonzaMonza, 20052, Italy
Completed
A.O.U. di BolognaBologna, 40138, Italy
Completed
A.O. Spedali CiviliBrescia, 25123, Italy
Completed
A.O.U. di FerraraFerrara, 44100, Italy
Completed
IRCCS Ist Auxologico ItalianoMilano, 20143, Italy
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
A.O.U. Ospedali Riuniti TriesteTrieste, 34149, Italy
Completed
A.O. Osp Circolo e Fond.MacchiVarese, 21100, Italy
Completed
A.O.U. Ospedali Riuniti Umberto I - Lancisi - SalesiAncona, 60126, Italy
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
ASL RM/B Roma - LazioRoma, 00157, Italy
Completed
ARNAS GaribaldiCatania, 95126, Italy
Completed
A.O.U. di SassariSassari, 07100, Italy
Completed
AULSS 09 Treviso - VenetoTreviso, 31100, Italy
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Hospital SAS de JerezJerez de la Frontera, 11407, Spain
Completed
Hospital Regional Carlos HayaMálaga, 29010, Spain
Completed
Centro de Salud Ingeniero Joaquín BenllochValencia, 46006, Spain
Completed
ASL Prov Pavia - LombardiaBroni, 27043, Italy
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Completed
A.O. Sant'Antonio AbateSomma Lombardo, 21013, Italy
Completed
AUSL 4 L'Aquila - AbruzzoL'Aquila, 67100, Italy
Completed
A.O. di PerugiaPerugia, 06129, Italy
Completed
A.O. San Camillo-ForlaniniRoma, 00152, Italy
Completed
Azienda Policlinico Umberto IRoma, 00161, Italy
Completed
A.O.U. Policlinico Paolo GiacconePalermo, 90127, Italy
Completed
IRCCS Ist Neurologico MediterraneoPozzilli, 86077, Italy
Completed
A.O. Umberto I di SiracusaSiracusa, 96100, Italy
Completed
Università di PaviaPavia, 27100, Italy
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital Dr. NegrínLas Palmas de Gran Canaria, 35020, Spain
Completed
Complexo Hospitalario Universitario de FerrolFerrol, 15405, Spain
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Terminated
Ospedale BassiniCinisello Balsamo, 20092, Italy
Terminated
A.O.U. Maggiore della CaritàNovara, 28100, Italy
Terminated
AULSS 12 Veneziana - VenetoVenezia, 30122, Italy
Terminated
A.O.U. SeneseSiena, 53100, Italy
Terminated
ASL NA 1 Napoli - CampaniaNapoli, 80136, Italy
Terminated
ASL NA 1 Napoli - CampaniaNapoli, 80141, Italy
Terminated
Hospital Universitario Infanta Cristina de BadajozBadajoz, 06080, Spain
Terminated
Hospital General de Ciudad RealCiudad Real, 13005, Spain
Terminated
Hospital de CabueñesGijón, 33394, Spain
Terminated
Centro de Salud BeniganimBeniganim, 46830, Spain

Primary Outcome

  • The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM)
    date_rangeTime Frame:
    at 16 weeks of treatment compared to baseline
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Office blood pressure, response rate (> 10mmHg decrease control rate (< 130/80) mean SBP, mean DBP.
    date_rangeTime Frame:
    8, 16 weeks of treatment
    enhanced_encryption
    Safety Issue:
    no
  • ABPM: % patients achieving BP < 125/80 mmHg morning BP increase/surge,24h mean diastolic BP,day average BP, night average BP,BP variability, pulse pressure through to peak ratio,smoothness index dipping or non dipping
    date_rangeTime Frame:
    8, 16 and 24 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Microalbuminuria in subgroup (any reduction)
    date_rangeTime Frame:
    8, 16 and 24 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Metabolic parameters: fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides
    date_rangeTime Frame:
    8, 16 and 24 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Inflammatory markers: sRAGE (soluble receptors for advanced glycation end products) eotaxin-3, CRP (C-Reactive Protein)
    date_rangeTime Frame:
    8, 16 and 24 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

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

Additional Information

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