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Sponsored by: |
Federico II University |
Information provided by: | Federico II University |
ClinicalTrials.gov Identifier: | NCT00687206 |
Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. On the other hand, the last American and European guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. In agreement with these recommendations we share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. On this basis, we decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage.
The aim of this study is to assess if an early and adeguate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function
Condition | Intervention | Phase |
Hypertension Ventricular Remodeling Erectile Dysfunctions |
Drug: Valsartan 160mg plus HCT 25mg |
Phase IV |
MedlinePlus related topics: | Erectile Dysfunction High Blood Pressure |
ChemIDplus related topics: | Valsartan |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Efficacy and Safety of Valsartan 160 mg Plus Hydroclorothiazide 25 mg Once a Day in Patients With Slight Hypertension and Target Organ Damage |
Estimated Enrollment: | 20 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Valsartan 160mg plus HCT 25mg
valsartan 160 mg plus hydroclorothiazide 25 mg a tablet once a day for 6 months
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Serafino Fazio, MD | 39-081-746-3737 | fazio@unina.it |
Contact: Antonio Ruvolo, MD | 39-081-746-3737 | ruvantonio@libero.it |
Italy | |||||
Department of internal medicine University Federico II | Recruiting | ||||
Naples, Italy, 80131 | |||||
Contact: Serafino Fazio, MD 39-081-746-3737 fazio@unina.it |
Federico II University |
Principal Investigator: | Serafino Fazio, MD | University of Naples Federico II |
Responsible Party: | Federico II University ( Serafino Fazio MD ) |
Study ID Numbers: | Val25/08 |
First Received: | May 19, 2008 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00687206 |
Health Authority: | Italy: The Italian Medicines Agency |
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