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

Condition(s) targeted: Hypertension

Intervention: Nifidipine (Drug); Telmisartan (Drug); Nifedipine/Telmisartan (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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

Official title: A Multicenter Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control and Beyond: Comparison of Two Treatment Strategies.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Primary outcome: The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM)

Secondary outcome:

Office blood pressure, response rate (> 10mmHg decrease control rate (< 130/80) mean SBP, mean DBP.

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

Microalbuminuria in subgroup (any reduction)

Metabolic parameters: fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides

Inflammatory markers: sRAGE (soluble receptors for advanced glycation end products) eotaxin-3, CRP (C-Reactive Protein)

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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 sparing diuretics.

- 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.

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Bologna 40138, Italy; Recruiting

Brescia 25123, Italy; Recruiting

Ferrara 44100, Italy; Recruiting

Pavia 27100, Italy; Recruiting

Milano 20145, Italy; Recruiting

Novara 28100, Italy; Not yet recruiting

Padova 35128, Italy; Recruiting

Reggio Emilia 42100, Italy; Recruiting

Trieste 34149, Italy; Recruiting

Varese 21100, Italy; Recruiting

Venezia 30122, Italy; Not yet recruiting

Ancona 60126, Italy; Recruiting

L'Aquila 67100, Italy; Recruiting

Perugia 06126, Italy; Recruiting

Pisa 56126, Italy; Recruiting

Roma 00151, Italy; Recruiting

Roma 00155, Italy; Recruiting

Roma 00157, Italy; Recruiting

Siena 53100, Italy; Not yet recruiting

Catania 95124, Italy; Recruiting

Napoli 80136, Italy; Terminated

Napoli 80141, Italy; Terminated

Palermo 90129, Italy; Recruiting

Sassari 07100, Italy; Recruiting

Siracusa 96100, Italy; Recruiting

Treviso 31100, Italy; Recruiting

Badajoz 06080, Spain; Not yet recruiting

Ciudad Real 13005, Spain; Terminated

Las Palmas de Gran Canaria 35020, Spain; Recruiting

Madrid 28041, Spain; Recruiting

Madrid 28040, Spain; Recruiting

Málaga 29010, Spain; Recruiting

Valencia 46006, Spain; Recruiting

Ferrol, A Coruña 15405, Spain; Recruiting

Gijón, Asturias 33394, Spain; Terminated

Badalona, Barcelona 08916, Spain; Recruiting

Jerez de la Frontera, Cádiz 11407, Spain; Recruiting

Pozzilli, Isernia 86077, Italy; Recruiting

Monza, Milano 20052, Italy; Recruiting

Cinisello Balsamo, Milano 20092, Italy; Terminated

Beniganim, Valencia 46830, Spain; Not yet recruiting

Gallarate, Varese 21013, Italy; Recruiting

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Starting date: October 2007
Ending date: June 2009
Last updated: February 5, 2009