Antihypertensive Efficacy of Fixed Combination Drug

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lercanidipine-enalapril fixed combination

uncontrolled hypertensive patients will receive fixed combination therapy

Group Type EXPERIMENTAL

Lercanidipine/enalapril fixed combination

Intervention Type DRUG

Lercanidipine 10 mg + enalapril 20 mg, once a day, used as a fixed combination drug. Unique dose during the study

Interventions

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Lercanidipine/enalapril fixed combination

Lercanidipine 10 mg + enalapril 20 mg, once a day, used as a fixed combination drug. Unique dose during the study

Intervention Type DRUG

Other Intervention Names

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Vasodip Combo 20 hypertension ambulatory blood pressure monitoring

Eligibility Criteria

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Inclusion Criteria

1. Essential hypertension at visit 1 defined as office blood pressure \<140/90 mmHg and a 24 h ABPM \>130/80 mmHg with a day time blood pressure (extracted from the 24h ABPM) \>135/85 mmHg
2. Male and female
3. Age 18-80
4. Every patient that in the medical opinion of the treating physician is eligible for Vasodip Combo 20 treatment.
5. Willing to sign an informed consent

Exclusion Criteria

1. Use of more than 2 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)
2. Mean 24 h ABPM values of more than 180/100 mmHg
3. Pregnant women
4. Women with potential age of pregnancy.
5. Suspected secondary hypertension (investigator decision)
6. Uncontrolled Diabetes Mellitus(investigator decision)
7. Any of the following in the last six months: Myocardial Infarction, Stroke, Coronary by-pass surgery, Percutaneous coronariography with balloon dilation and/or stent insertion
8. Congestive Heart Failure requiring pharmacological treatment
9. Renal Failure, defined as serum creatinine equal or great than 1.5 mg% \[confirmed twice\] or hyperkalemia defined as serum potassium equal or great that 5 meq/l \[confirmed twice\]
10. Malignancy that required Chemotherapy in the last 3 years.
11. Any medical or none medical condition that in the eyes of the investigator will not allow the patient to complete the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No