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Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00750113 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control and Beyond: Comparison of Two Treatment Strategies. |
Estimated Enrollment: | 255 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: Nifidipine
Tablets 20 Mg daily for 4 weeks then combination therapy
|
Arm 2: Experimental |
Drug: Telmisartan
Tablets 80 Mg daily for 4 weeks then combination therapy
|
Arm 3: Experimental |
Drug: Nifedipine/Telmisartan
2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
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.
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 12313, EudraCT Nr: 2006-006436-22 |
Study First Received: | September 9, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00750113 History of Changes |
Health Authority: | European Union: European Medicines Agency; Italy: Ministry of Health; Spain: Ministry of Health |
Angiotensin II Type 1 Receptor Blockers Calcium, Dietary Vasodilator Agents Vascular Diseases Angiotensin-Converting Enzyme Inhibitors Calcium Channel Blockers |
Cardiovascular Agents Telmisartan Angiotensin II Nifedipine Protease Inhibitors Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vascular Diseases Calcium Channel Blockers Enzyme Inhibitors Reproductive Control Agents Cardiovascular Agents Nifedipine Pharmacologic Actions |
Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Tocolytic Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |