NCT01017835

Brief Summary

The purpose of this study is to determine whether combined therapy with simvastatin and hypotensive drugs (ACEI or ARB) may decrease the blood pressure. Moreover, we would like to assess the influence of isolated hypertension on endothelial injury, and on the development of atherosclerosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 23, 2009

Status Verified

November 1, 2009

Enrollment Period

1.6 years

First QC Date

November 20, 2009

Last Update Submit

November 20, 2009

Conditions

Keywords

statinsisolated hypertensionatherosclerosislipid profile

Study Arms (2)

statin treatment, isolated hypertension

treatment with statins, patients with isolated hypertension, with no hyperlipidemia, no diabetes, no smoking

placebo treatment, isolated hypertension

treatment with placebo, patients with isolated hypertension, with no hyperlipidemia, no diabetes, no smoking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized in the Department of Nephrology, Hypertension and Family Medicine,Clinical Hospital of Medical University of Lodz

You may qualify if:

  • isolated hypertension (I or II class according to ESH guidelines 2009)

You may not qualify if:

  • ischemic heart disease, prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG), heart failure, diabetes, hyperlipidemia, active smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departament of Nephrology, Hypertension and Family Medicine, Clinical Hospital of Medical University of Lodz

Lodz, 90-549, Poland

RECRUITING

Related Publications (3)

  • Stepien M, Banach M, Mikhailidis DP, Gluba A, Kjeldsen SE, Rysz J. Role and significance of statins in the treatment of hypertensive patients. Curr Med Res Opin. 2009 Aug;25(8):1995-2005. doi: 10.1185/03007990903098081.

    PMID: 19555312BACKGROUND
  • Rysz J, Aronow WS, Stolarek RS, Hannam S, Mikhailidis DP, Banach M. Nephroprotective and clinical potential of statins in dialyzed patients. Expert Opin Ther Targets. 2009 May;13(5):541-50. doi: 10.1517/14728220902882130.

    PMID: 19368496BACKGROUND
  • Szadkowska I, Stanczyk A, Aronow WS, Kowalski J, Pawlicki L, Ahmed A, Banach M. Statin therapy in the elderly: a review. Arch Gerontol Geriatr. 2010 Jan-Feb;50(1):114-8. doi: 10.1016/j.archger.2008.12.012. Epub 2009 Feb 13.

    PMID: 19217673BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

HypertensionAtherosclerosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Maciej Banach, MD PhD

    Departament of Hypertension , Medical University of Lodz

    STUDY CHAIR

Central Study Contacts

Marta Michalska, MSc

CONTACT

Maciej Banach, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2011

Study Completion

January 1, 2012

Last Updated

November 23, 2009

Record last verified: 2009-11

Locations