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 |
| Protocol serial number | N/A |
| Sponsor | Astra Zeneca (Germany) |
| Funder | Astra Zeneca (Germany) |
- 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
Scientific
Wilhelmstr 35-37
Bonn
53111
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Candesartan and hydrochlorothiazide |
| Primary outcome measure(s) |
1. Drug compliance |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 02/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 62 |
| Key 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) |
| Key exclusion criteria | 1. Pregnancy 2. Known intolerance of HCTZ or Angiotensin II Type One Receptor Blockers (AT1-Blockers) 3. Secondary hypertension |
| Date of first enrolment | 02/01/2001 |
| Date of final enrolment | 02/01/2003 |
Locations
Countries of recruitment
- Germany
Study participating centre
Wilhelmstr 35-37
Bonn
53111
Germany
53111
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
