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Fixed vs Free Dose of ACEi/CCB Combination Therapy (FixFree)

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ClinicalTrials.gov Identifier: NCT02995954
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Guido Iaccarino, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Perindopril/Amlodipine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blood Pressure Reduction by Fixed-dose Compared to Free Dose Combination Therapy of ACE Inhibitor and Calcium Antagonist in Hypertensive Patients
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fixed
The Fixed group received one single tablet containing Perindopril/Amlodipine (Reaptan) at the appropriate dose
Drug: Perindopril/Amlodipine
Single table containing Perindopril/Amlodipine
Other Name: Perindopril amlodipine

Active Comparator: Free
The Free group, received Perindopril and Amlodipine in separate tablets at the appropriate dose
Drug: Perindopril/Amlodipine
Single table containing Perindopril/Amlodipine
Other Name: Perindopril amlodipine




Primary Outcome Measures :
  1. systolic Blood pressure control [ Time Frame: 3 months ]
    reduction in mmHg

  2. Diastolic Blood pressure control [ Time Frame: 3 months ]
    reduction in mmHg


Secondary Outcome Measures :
  1. blood pressure control [ Time Frame: 3 months ]
    percentage of patients with BP control



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995954


Locations
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Italy
San Giovanni e Ruggi Hospital
Salerno, Italy, 84100
Sponsors and Collaborators
Guido Iaccarino

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Responsible Party: Guido Iaccarino, Associate Professor of Internal of Medicine, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
ClinicalTrials.gov Identifier: NCT02995954     History of Changes
Other Study ID Numbers: iacca001
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Guido Iaccarino, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona:
Combination therapy
ACE inhibitor Calcium Antagonist

Additional relevant MeSH terms:
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Calcium
Amlodipine
Perindopril
Calcium Channel Blockers
Angiotensin-Converting Enzyme Inhibitors
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antihypertensive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protease Inhibitors
Enzyme Inhibitors