Status:
TERMINATED
Antihypertensive Efficacy of Fixed Combination Drug
Lead Sponsor:
Meir Medical Center
Collaborating Sponsors:
Dexcel Pharma Technologies Ltd.
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 ach...
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 inclusi...
Eligibility Criteria
Inclusion
- 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
- Male and female
- Age 18-80
- Every patient that in the medical opinion of the treating physician is eligible for Vasodip Combo 20 treatment.
- Willing to sign an informed consent
Exclusion
- Use of more than 2 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)
- Mean 24 h ABPM values of more than 180/100 mmHg
- Pregnant women
- Women with potential age of pregnancy.
- Suspected secondary hypertension (investigator decision)
- Uncontrolled Diabetes Mellitus(investigator decision)
- 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
- Congestive Heart Failure requiring pharmacological treatment
- 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 \[confirmed twice\]
- Malignancy that required Chemotherapy in the last 3 years.
- Any medical or none medical condition that in the eyes of the investigator will not allow the patient to complete the study.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01211314
Start Date
January 1 2011
End Date
April 1 2012
Last Update
June 28 2016
Active Locations (1)
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1
Clalit Health Services
Herzliya, Hasharon, Israel