Antihypertensive Efficacy of Fixed Combination Drug

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01211314
• Other study ID #: EDU1952
• Status: Terminated
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: June 26, 2016
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Israel	Clalit Health Services	Hertsliyah	Hasharon

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Dexcel Pharma Technologies Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Hair PI, Scott LJ, Perry CM. Fixed-dose combination lercanidipine/enalapril. Drugs. 2007;67(1):95-106; discussion 107-8. Review. — View Citation

Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clément D, Coca A, Dominiczak A, Erdine S, Fagard R, Farsang C, Grassi G, Haller H, Heagerty A, Kjeldsen SE, Kiowski W, Mallion JM, Manolis A, Narkiewicz K, Nilsson P, Olsen MH, Rahn KH, Redon J, Rodicio J, Ruilope L, Schmieder RE, Struijker-Boudier HA, Van Zwieten PA, Viigimaa M, Zanchetti A. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009;18(6):308-47. doi: 10.3109/08037050903450468. — View Citation

Menne J, Haller H. Fixed-dose lercanidipine/enalapril for hypertension. Drugs Today (Barc). 2008 Apr;44(4):261-70. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure control	Percentage of patients with controlled blood pressure with office BP and 24 h ABPM measurements, from baseline to week 4.	Four weeks	Yes