Hypertension Clinical Trial
— FixFreeOfficial title:
Blood Pressure Reduction by Fixed-dose Compared to Free Dose Combination Therapy of ACE Inhibitor and Calcium Antagonist in Hypertensive Patients
The introduction of fixed combination of ACEi+CCB (Fixed) has significantly increased
patients compliance and adherence to therapy. At the moment, however, there are no data
suggesting the better control of once-daily fixed (Fixed) over free doses in separate
administrations combination therapy in hypertensives.
In a population of 39 consecutive outpatient patients referred to the departmental
Hypertension clinic of the University Hospital of Salerno Medical School with the first
diagnosis of arterial hypertension, the investigators tested the hypothesis that the Fixed
achieve a better control of blood pressure than the Free combination. Patients were
randomized to either strategy and after 3 months patients underwent a clinical assessment to
evaluate the antihypertensive effect.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Hypertensive patients with the first diagnosis of arterial hypertension and in the absence of a previous treatment. Exclusion Criteria: - Patients were excluded if patients had secondary hypertension, malignant hypertension, CRF (chronic renal failure), oncological conditions or cirrhosis. - Patients were also excluded if patients had medical and surgical disorders that alter absorption, distribution, metabolism and excretion of drug treatment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | San Giovanni e Ruggi Hospital | Salerno |
Lead Sponsor | Collaborator |
---|---|
Guido Iaccarino |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | systolic Blood pressure control | reduction in mmHg | 3 months | No |
Primary | Diastolic Blood pressure control | reduction in mmHg | 3 months | No |
Secondary | blood pressure control | percentage of patients with BP control | 3 months | No |
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