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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

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

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

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

Summary

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

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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)

Eligibility

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 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 and Contacts

Ancona 60126, Italy

Bologna 40138, Italy

Brescia 25123, Italy

Broni 27043, Italy

Catania 95126, Italy

Cinisello Balsamo 20092, Italy

Ferrara 44100, Italy

L'Aquila 67100, Italy

Milano 20143, Italy

Napoli 80136, Italy

Napoli 80141, Italy

Novara 28100, Italy

Padova 35128, Italy

Palermo 90127, Italy

Pavia 27100, Italy

Perugia 06129, Italy

Pisa 56126, Italy

Reggio Emilia 42100, Italy

Roma 00152, Italy

Roma 00157, Italy

Roma 00161, Italy

Sassari 07100, Italy

Siena 53100, Italy

Siracusa 96100, Italy

Treviso 31100, Italy

Trieste 34149, Italy

Varese 21100, Italy

Venezia 30122, Italy

Badajoz 06080, Spain

Ciudad Real 13005, Spain

Madrid 28040, Spain

Madrid 28041, Spain

Málaga 29010, Spain

Valencia 46006, Spain

Ferrol, A Coruña 15405, Spain

Gijón, Asturias 33394, Spain

Badalona, Barcelona 08916, Spain

Jerez de la Frontera, Cádiz 11407, Spain

Pozzilli, Isernia 86077, Italy

Las Palmas de Gran Canaria, Las Palmas 35020, Spain

Monza, Monza-Brianza 20052, Italy

Beniganim, Valencia 46830, Spain

Somma Lombardo, Varese 21013, Italy

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Click here and search for Bayer Product infromation provided by EMA

Starting date: October 2007
Last updated: December 4, 2014

Page last updated: August 23, 2015

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