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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00750113 |
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Nifidipine Drug: Telmisartan Drug: Nifedipine/Telmisartan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control and Beyond: Comparison of Two Treatment Strategies. |
| Enrollment: | 405 |
| Study Start Date: | October 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Nifidipine
Tablets 20 Mg daily for 4 weeks then combination therapy
|
| Experimental: Arm 2 |
Drug: Telmisartan
Tablets 80 Mg daily for 4 weeks then combination therapy
|
| Experimental: Arm 3 |
Drug: Nifedipine/Telmisartan
2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Pozzilli, Isernia, Italy, 86077 | |
| Monza, Monza-Brianza, Italy, 20052 | |
| Gallarate, Varese, Italy, 21013 | |
| Ancona, Italy, 60126 | |
| Bologna, Italy, 40138 | |
| Brescia, Italy, 25123 | |
| Catania, Italy, 95123 | |
| Ferrara, Italy, 44100 | |
| L'Aquila, Italy, 67100 | |
| Milano, Italy, 20145 | |
| Padova, Italy, 35128 | |
| Palermo, Italy, 90127 | |
| Pavia, Italy, 27100 | |
| Perugia, Italy, 06156 | |
| Pisa, Italy, 56126 | |
| Reggio Emilia, Italy, 42100 | |
| Roma, Italy, 00161 | |
| Roma, Italy, 00151 | |
| Roma, Italy, 00157 | |
| Sassari, Italy, 07100 | |
| Siracusa, Italy, 96100 | |
| Treviso, Italy, 31100 | |
| Trieste, Italy, 34100 | |
| Varese, Italy, 21100 | |
| Spain | |
| Ferrol, A Coruña, Spain, 15405 | |
| Badalona, Barcelona, Spain, 08916 | |
| Jerez de la Frontera, Cádiz, Spain, 11407 | |
| Las Palmas de Gran Canaria, Spain, 35020 | |
| Madrid, Spain, 28041 | |
| Madrid, Spain, 28040 | |
| Málaga, Spain, 29010 | |
| Valencia, Spain, 46006 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00750113 History of Changes |
| Other Study ID Numbers: | 12313, EudraCT Nr: 2006-006436-22 |
| Study First Received: | September 9, 2008 |
| Last Updated: | June 13, 2011 |
| Health Authority: | European Union: European Medicines Agency; Italy: Ministry of Health; Spain: Ministry of Health |
|
Hypertension Vascular Diseases Cardiovascular Diseases Nifedipine Telmisartan Benzoates Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |