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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006436-22 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifidipine | Drug | Tablets 20 Mg daily for 4 weeks then combination therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pozzilli | Isernia | 86077 | Italy | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21252701 | Result | 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. |
| Label | URL |
|---|---|
| Click here and search for Bayer Product infromation provided by EMA | View source |
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| Telmisartan |
| Drug |
Tablets 80 Mg daily for 4 weeks then combination therapy |
|
| Nifedipine/Telmisartan | Drug | 2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning |
|
| 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 |
| Monza |
| Monza-Brianza |
| 20052 |
| Italy |
| Somma Lombardo | Varese | 21013 | Italy |
| 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 |
| Milan | 20143 | Italy |
| Naples | 80136 | Italy |
| Naples | 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 |
| Syracuse | 96100 | Italy |
| Treviso | 31100 | Italy |
| Trieste | 34149 | Italy |
| Varese | 21100 | Italy |
| Venezia | 30122 | Italy |
| Ferrol | A Coruña | 15405 | Spain |
| Badajoz | Badajoz | 06080 | Spain |
| Badalona | Barcelona | 08916 | Spain |
| Ciudad Real | Ciudad Real | 13005 | Spain |
| Jerez de la Frontera | Cádiz | 11407 | Spain |
| Las Palmas de Gran Canaria | Las Palmas | 35020 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Málaga | Málaga | 29010 | Spain |
| Gijón | Principality of Asturias | 33394 | Spain |
| Benigànim | Valencia | 46830 | Spain |
| Valencia | Valencia | 46006 | Spain |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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