Management of patients with uncontrolled arterial hypertension - the role of electronic compliance monitoring, 24 hour ambulatory blood pressure monitoring and candesartan/hydrochlorothiazide (HCTZ)

ISRCTN ISRCTN02311110
DOI https://doi.org/10.1186/ISRCTN02311110
Secondary identifying numbers N/A
Submission date
05/07/2006
Registration date
26/07/2006
Last edited
24/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Thomas Mengden
Scientific

Wilhelmstr 35-37
Bonn
53111
Germany

Study information

Study designSingle-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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(s)Ethics approval gained from the Ethics Committee of the university of Bonn on 12th December 2000 (reference No.:150/00).
Health condition(s) or problem(s) studiedResistant arterial hypertension
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Candesartan and hydrochlorothiazide
Primary outcome measure1. Drug compliance
2. Blood pressure
Secondary outcome measuresNot provided at time of registration
Overall study start date02/01/2001
Completion date02/01/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants62
Key inclusion criteriaPatients with essential hypertension and office Blood Pressure (oBP) more than or equal to 140/90 mmHg, despite combination therapy (more than two antihypertensive drugs)
Key exclusion criteria1. Pregnancy
2. Known intolerance of HCTZ or Angiotensin II Type One Receptor Blockers (AT1-Blockers)
3. Secondary hypertension
Date of first enrolment02/01/2001
Date of final enrolment02/01/2003

Locations

Countries of recruitment

  • Germany

Study participating centre

Wilhelmstr 35-37
Bonn
53111
Germany

Sponsor information

Astra Zeneca (Germany)
Industry

AstraZeneca GmbH
Wedel
22880
Germany

ROR logo "ROR" https://ror.org/054q96n74

Funders

Funder type

Industry

Astra Zeneca (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 30/08/2006 Yes No