NCT02377661

Brief Summary

The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

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

February 16, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

February 16, 2015

Last Update Submit

August 15, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Achievement of the target office blood pressure (< 140/90 mmHg)

    Proportion of patients achieving the target office blood pressure of 140/90 mmHg

    6 months

  • Achievement of the target systolic office blood pressure (< 140 mmHg)

    Proportion of patients achieving the target systolic office blood pressure of 140 mmHg

    6 months

  • Achievement of the target diastolic office blood pressure (< 90 mmHg)

    Proportion of patients achieving the target diastolic office blood pressure of 90 mmHg

    6 months

Secondary Outcomes (6)

  • Achievement of the target average 24h systolic ambulatory blood pressure (< 130 mmHg)

    6 months

  • Achievement of the target average 24h diastolic ambulatory blood pressure (< 80 mmHg)

    6 months

  • Achievement of the target average daytime systolic ambulatory blood pressure (< 135 mmHg)

    6 months

  • Achievement of the target average nighttime systolic ambulatory blood pressure (< 120 mmHg)

    6 months

  • Achievement of the target average daytime diastolic ambulatory blood pressure (< 85 mmHg)

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Standard Care

NO INTERVENTION

Treatment of hypertension according to current guidelines

Experimental Care

EXPERIMENTAL

Treatment of hypertension using a standardised and simplified titration regime with single pill combinations, comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.

Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazide

Interventions

Olmesartan medoxomil, amlodipine, hydrochlorothiazideDRUG

Up-titration of antihypertensive therapy with single pill combinations (comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide) in 4-week intervals if the target blood pressure of \< 140/90 mmHg is not reached at the respective follow-up

Experimental Care

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • office blood pressure ≥ 140/90 mmHg
  • ACE inhibitor intolerance (experimental arm)

You may not qualify if:

  • Malignant disease with life expectancy \< 6 months
  • Women of childbearing potential (ICH definition) or breastfeeding
  • Contraindications or allergies against olmesartan, amlodipine or hydrochlorothiazide (experimental arm)
  • Chronic kidney disease grade IV or V (eGFR \< 30 ml/min)
  • Recent myocardial infarction or stroke within the preceding 3 months
  • Participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GP practices

Vienna, Austria

Location

Related Publications (1)

  • Rohla M, Tscharre M, Huber K, Weiss TW. Lowering blood pressure in primary care in Vienna (LOW-BP-VIENNA) : A cluster-randomized trial. Wien Klin Wochenschr. 2018 Dec;130(23-24):698-706. doi: 10.1007/s00508-018-1374-4. Epub 2018 Aug 15.

    PMID: 30112584DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Olmesartan MedoxomilAmlodipineHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesDihydropyridinesPyridinesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Thomas W Weiss, MD, PhD

    3rd Medical Department, Cardiology and Intensive Care Medicine Wilhelminenhospital, 1160 Vienna, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 3, 2015

Study Start

March 1, 2015

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

AU(1)