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

NCT00750113 | Completed Phase 4

• 2 other identifiers: 123132006-006436-22
• Study Type: interventional
• Target: 405
• Locations: 2 countries
• Sites: 43

Brief 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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

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

  8, 16 weeks of treatment

• 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

  8, 16 and 24 weeks

• Microalbuminuria in subgroup (any reduction)

  8, 16 and 24 weeks

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

  8, 16 and 24 weeks

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

  8, 16 and 24 weeks

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Nifidipine

Arm 2

EXPERIMENTAL

Drug: Telmisartan

Arm 3

EXPERIMENTAL

Drug: Nifedipine/Telmisartan

Interventions

Nifidipine DRUG

Tablets 20 Mg daily for 4 weeks then combination therapy

Arm 1

Telmisartan DRUG

Tablets 80 Mg daily for 4 weeks then combination therapy

Arm 2

Nifedipine/Telmisartan DRUG

2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning

Arm 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (43)

Unknown Facility

Pozzilli, Isernia, 86077, Italy

Location

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Monza, Monza-Brianza, 20052, Italy

Location

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Somma Lombardo, Varese, 21013, Italy

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Ancona, 60126, Italy

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Bologna, 40138, Italy

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Brescia, 25123, Italy

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Broni, 27043, Italy

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Catania, 95126, Italy

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Cinisello Balsamo, 20092, Italy

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Ferrara, 44100, Italy

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L’Aquila, 67100, Italy

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Milan, 20143, Italy

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Napoli, 80136, Italy

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Napoli, 80141, Italy

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Novara, 28100, Italy

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Padua, 35128, Italy

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Palermo, 90127, Italy

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Pavia, 27100, Italy

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Perugia, 06129, Italy

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Pisa, 56126, Italy

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Reggio Emilia, 42100, Italy

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Roma, 00152, Italy

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Roma, 00157, Italy

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Roma, 00161, Italy

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Sassari, 07100, Italy

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Siena, 53100, Italy

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Syracuse, 96100, Italy

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Treviso, 31100, Italy

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Trieste, 34149, Italy

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Varese, 21100, Italy

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Venezia, 30122, Italy

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Ferrol, A Coruña, 15405, Spain

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Badajoz, Badajoz, 06080, Spain

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Badalona, Barcelona, 08916, Spain

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Ciudad Real, Ciudad Real, 13005, Spain

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Jerez de la Frontera, Cádiz, 11407, Spain

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Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28041, Spain

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Málaga, Málaga, 29010, Spain

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Gijón, Principality of Asturias, 33394, Spain

Location

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Benigànim, Valencia, 46830, Spain

Location

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Valencia, Valencia, 46006, Spain

Location

Related Publications (1)

• Mancia G, Parati G, Bilo G, Choi J, Kilama MO, Ruilope LM; TALENT investigators. Blood pressure control by the nifedipine GITS-telmisartan combination in patients at high cardiovascular risk: the TALENT study. J Hypertens. 2011 Mar;29(3):600-9. doi: 10.1097/HJH.0b013e328342ef04.

  PMID: 21252701 RESULT

Related Links

• Click here and search for Bayer Product infromation provided by EMA

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

IT (31); ES (12)