NCT01211314

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 28, 2016

Status Verified

August 1, 2011

Enrollment Period

11 months

First QC Date

September 28, 2010

Last Update Submit

June 26, 2016

Conditions

Hypertension

Keywords

hypertensionFixed combinationlercanidipineenalaprilBlood Pressure Monitoring, Ambulatory

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

lercanidipine-enalapril fixed combination

EXPERIMENTAL

uncontrolled hypertensive patients will receive fixed combination therapy

Drug: Lercanidipine/enalapril fixed combination

Interventions

Lercanidipine/enalapril fixed combinationDRUG

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
lercanidipine-enalapril fixed combination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services

Herzliya, Hasharon, Israel

Location

Related Publications (3)

  • Hair PI, Scott LJ, Perry CM. Fixed-dose combination lercanidipine/enalapril. Drugs. 2007;67(1):95-106; discussion 107-8. doi: 10.2165/00003495-200767010-00007.

    PMID: 17209666BACKGROUND

  • Menne J, Haller H. Fixed-dose lercanidipine/enalapril for hypertension. Drugs Today (Barc). 2008 Apr;44(4):261-70. doi: 10.1358/dot.2008.44.4.1164756.

    PMID: 18536784BACKGROUND

  • Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clement 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. No abstract available.

    PMID: 20001654BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

lercanidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Eduardo Podjarny, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 29, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

June 28, 2016

Record last verified: 2011-08

Data Sharing

IPD Sharing
Will share

Locations

IL(1)