Fixed vs Free Dose of ACEi/CCB Combination Therapy
FixFree
Blood Pressure Reduction by Fixed-dose Compared to Free Dose Combination Therapy of ACE Inhibitor and Calcium Antagonist in Hypertensive Patients
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 19, 2016
CompletedDecember 19, 2016
December 1, 2016
1.9 years
December 13, 2016
December 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
systolic Blood pressure control
reduction in mmHg
3 months
Diastolic Blood pressure control
reduction in mmHg
3 months
Secondary Outcomes (1)
blood pressure control
3 months
Study Arms (2)
Fixed
ACTIVE COMPARATORThe Fixed group received one single tablet containing Perindopril/Amlodipine (Reaptan) at the appropriate dose
Free
ACTIVE COMPARATORThe Free group, received Perindopril and Amlodipine in separate tablets at the appropriate dose
Interventions
Single table containing Perindopril/Amlodipine
Eligibility Criteria
You may qualify if:
- Hypertensive patients with the first diagnosis of arterial hypertension and in the absence of a previous treatment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guido Iaccarinolead
Study Sites (1)
San Giovanni e Ruggi Hospital
Salerno, Salerno, 84100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Internal of Medicine
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 19, 2016
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 19, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share