A Phase 4 interventional study of Lercanidipine/enalapril fixed combination in Hypertension, sponsored by Meir Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-28.
Sponsored by Meir Medical Center · Phase 4, Interventional, and Treatment
Treatment and control of hypertension is still insufficient. About 50% of the patients remain uncontrolled. Lack of compliance with discontinuation of drug treatment is an important reason for not achieving blood pressure. Several studies have shown that use of fixed combinations improve compliance significantly, by reducing the number of pill's intake.
This study will assess the antihypertensive efficacy of Vasodip-Combo 20® [enalapril 20 mg + lercanidipine 10 mg] as a fixed combination drug in uncontrolled antihypertensive patients.
This is a single centre observational uncontrolled prospective study, Hypertensive patients that are either treatment naïve or uncontrolled on current therapy [one or two drugs] and meet all inclusion and exclusion criteria, will be assigned to Vasodip-Combo 20 as unique drug treatment. The treatment will then be continued for additional 4 weeks. Office blood pressure will be performed by the physician at each visit. 24 h. ambulatory blood pressure measurements [ABPM] and blood samples for electrolytes, creatinine and urea will be taken at base line visit and at at week 4.
Efficacy will be defined in terms of therapeutic goals expressed as target blood pressures according to World Health Organization and European society of Hypertension [ for office blood pressure and ambulatory blood pressure measurements] criteria:
Office Blood Pressure: Diastolic blood pressure ≤ 90 mmHg and Systolic blood pressure ≤ 140 mmHg for non-diabetics or Diastolic Blood Pressure ≤ 80 mmHg and Systolic Blood Pressure ≤ 130 mmHg for diabetics, respectively.
24 h Ambulatory Blood Pressure Measurements: 224 Hour: Diastolic Blood Pressure≤ 80 mmHg and Systolic Blood Pressure ≤ 130 mmHg, Awake time: Diastolic Blood Pressure ≤ 85 mmHg,Systolic Blood Pressure ≤ 135 mmHg Asleep Time: Diastolic Blood Pressure ≤70 mmHg, Systolic Blood Pressure ≤ 70 mmHg.
Effectiveness and Safety will also be evaluated taking into consideration patient compliance
Safety assessments:
Safety will be assessed by means of (S)Adverse effects reporting.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
uncontrolled hypertensive patients will receive fixed combination therapy
Drug: Lercanidipine/enalapril fixed combination
Lercanidipine 10 mg + enalapril 20 mg, once a day, used as a fixed combination drug. Unique dose during the study
Also known as: Vasodip Combo 20, hypertension, ambulatory blood pressure monitoring
Blood Pressure control
Percentage of patients with controlled blood pressure with office BP and 24 h ABPM measurements, from baseline to week 4.
Time frame: Four weeks
Plan to share: Yes
This study is terminated, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Meir Medical Center