Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Candesartan and hydrochlorothiazide
Primary outcome measure
1. Drug compliance
2. Blood pressure
Secondary outcome measures
Not provided at time of registration
Overall study start date
02/01/2001
Overall study end date
02/01/2003
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/08/2006 | Yes | No |