Condition category
Circulatory System
Date applied
05/07/2006
Date assigned
26/07/2006
Last edited
24/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Mengden

ORCID ID

Contact details

Wilhelmstr 35-37
Bonn
53111
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The aim of the present study was:
1. To compare drug regimen compliance in hypertensives treated with combination therapy whose blood pressure (BP) was controlled versus uncontrolled after four weeks of self-monitored BP measurement.
2. To observe the consequences in uncontrolled patients of switching one drug of the combination therapy to candesartan/HCTZ (16 mg/12.5 mg) with and without a compliance intervention program.

Ethics approval

Ethics approval gained from the Ethics Committee of the university of Bonn on 12th December 2000 (reference No.:150/00).

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Resistant arterial hypertension

Intervention

Patients with oBP of more than 140/90 mmHg despite combination therapy were begun on microelectromechanical systems (MEMS) monitoring and self BP measurement for four weeks of run-in.

Of 62 such patients, 18 (29%) were normotensive according to self BP measurement and ambulatory BP measurement at four weeks (Group A); in the remaining 44 still uncontrolled patients, candesartan/HCTZ was substituted for one of the combination therapy drugs, with half these patients receiving passive compliance monitoring (Group B) and the other half in the Drug Regimen Compliance (DRC) intervention program (Group C).

All groups were then followed for eight weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Candesartan and hydrochlorothiazide

Primary outcome measures

1. Drug compliance
2. Blood pressure

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/01/2001

Overall trial end date

02/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with essential hypertension and office Blood Pressure (oBP) more than or equal to 140/90 mmHg, despite combination therapy (more than two antihypertensive drugs)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

62

Participant exclusion criteria

1. Pregnancy
2. Known intolerance of HCTZ or Angiotensin II Type One Receptor Blockers (AT1-Blockers)
3. Secondary hypertension

Recruitment start date

02/01/2001

Recruitment end date

02/01/2003

Locations

Countries of recruitment

Germany

Trial participating centre

Wilhelmstr 35-37
Bonn
53111
Germany

Sponsor information

Organisation

Astra Zeneca (Germany)

Sponsor details

AstraZeneca GmbH
Wedel
22880
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Astra Zeneca (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16942618

Publication citations

  1. Results

    Mengden T, Vetter H, Tousset E, Uen S, Management of patients with uncontrolled arterial hypertension--the role of electronic compliance monitoring, 24-h ambulatory blood pressure monitoring and Candesartan/HCTZ., BMC Cardiovasc Disord, 2006, 6, 36, doi: 10.1186/1471-2261-6-36.

Additional files

Editorial Notes