Antihypertensive Efficacy of Fixed Combination Drug

June 26, 2016 updated by: Meir Medical Center

Treatment of Essential Hypertension With Vasodip-Combo 20. Efficacy and Safety Evaluation With 24 h Ambulatory Blood Pressure Measurements

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Hasharon
      • Hertsliyah, Hasharon, Israel
        • Clalit Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lercanidipine-enalapril fixed combination
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
Other Names:
  • Vasodip Combo 20
  • hypertension
  • ambulatory blood pressure monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure control
Time Frame: Four weeks
Percentage of patients with controlled blood pressure with office BP and 24 h ABPM measurements, from baseline to week 4.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Collaborators

Dexcel Pharma Technologies Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 26, 2016

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDU1952

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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