NCT02064218

Brief Summary

First of all to evaluate the relationship between non-conventional biomarkers and essential hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood pressure control and non-conventional biomarkers in naive hypertensive patients

Trial Health

55
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Trial Health Score

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

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, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
Last Updated

February 17, 2014

Status Verified

November 1, 2007

Enrollment Period

6.2 years

First QC Date

February 11, 2014

Last Update Submit

February 13, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure reduction

    * Systolic Blood Pressure (SBP) * Diastolic Blood Pressure (DBP)

    5 years

Secondary Outcomes (1)

  • Cardiovascular and metabolic biomarkers

    5 years

Other Outcomes (1)

  • Evaluation of vascular stiffness

    5 years

Study Arms (2)

Hypertensive patients

Hypertensive patients naive to hypertensive treatment

Drug: Anti-hypertensive drugs

healthy subjects

healthy subjects

Interventions

Anti-hypertensive drugsDRUG
Hypertensive patients

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with naive essential hypertension aged \< 65 years without previous cardiovascular events

You may qualify if:

  • essential hypertension
  • naive to treatment
  • \< 65 years

You may not qualify if:

  • secondary hypertension
  • previous cardiovascular events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico S.Matteo Foundation

Pavia, 27100, Italy

RECRUITING

Related Publications (5)

  • Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. Barnidipine compared to lercanidipine in addition to losartan on endothelial damage and oxidative stress parameters in patients with hypertension and type 2 diabetes mellitus. BMC Cardiovasc Disord. 2016 Apr 12;16:66. doi: 10.1186/s12872-016-0237-z.

    PMID: 27068332DERIVED

  • Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. Perindopril and barnidipine alone or combined with simvastatin on hepatic steatosis and inflammatory parameters in hypertensive patients. Eur J Pharmacol. 2015 Nov 5;766:31-6. doi: 10.1016/j.ejphar.2015.09.030. Epub 2015 Sep 25.

    PMID: 26407654DERIVED

  • Derosa G, Mugellini A, Querci F, Franzetti I, Pesce RM, D'Angelo A, Maffioli P. Barnidipine or Lercanidipine on Echocardiographic Parameters in Hypertensive, Type 2 Diabetics with Left Ventricular Hypertrophy: A Randomized Clinical Trial. Sci Rep. 2015 Aug 5;5:12603. doi: 10.1038/srep12603.

    PMID: 26243165DERIVED

  • Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. A study about the relevance of adding acetylsalicylic acid in primary prevention in subjects with type 2 diabetes mellitus: effects on some new emerging biomarkers of cardiovascular risk. Cardiovasc Diabetol. 2015 Jul 30;14:95. doi: 10.1186/s12933-015-0254-8.

    PMID: 26223257DERIVED

  • Derosa G, Romano D, Bianchi L, D'Angelo A, Maffioli P. The effects of canrenone on inflammatory markers in patients with metabolic syndrome. Ann Med. 2015 Feb;47(1):47-52. doi: 10.3109/07853890.2014.969303. Epub 2014 Oct 16.

    PMID: 25319120DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Giuseppe Derosa, MD, PhD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Derosa, MD, PhD

CONTACT

+39 0382 502614giuseppe.derosa@unipv.it

Amedeo Mugellini, MD, PhD

CONTACT

+39 0382 502614amedeo.mugellini@unipv.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 17, 2014

Study Start

November 1, 2007

Primary Completion

January 1, 2014

Last Updated

February 17, 2014

Record last verified: 2007-11

Locations

IT(1)