A novel approach to treatment of hypertension in diabetic patients - A multicenter, double-blind, randomised study comparing the efficacy of combination therapy of Eprosartan versus Ramipril with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with hypertension and associated diabetes mellitus type 2 - rationale and design.
| ISRCTN | ISRCTN55725285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55725285 |
| Protocol serial number | S171.3.012 |
| Sponsor | Solvay Pharmaceuticals (Germany) |
| Funder | GPS Solvay Pharmaceuticals |
- Submission date
- 12/10/2004
- Registration date
- 12/10/2004
- Last edited
- 06/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Cornel Pater
Scientific
Scientific
Hans-Boeckler Allee 20
Hannover
30173
Germany
| Phone | +49 (0)511 857 2074 |
|---|---|
| cornel.pater@solvay.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A novel approach to treatment of hypertension in diabetic patients - A multicenter, double-blind, randomised study comparing the efficacy of combination therapy of Eprosartan versus Ramipril with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with hypertension and associated diabetes mellitus type 2 - rationale and design. |
| Study acronym | ASTRID (Antihypertensive treatment of Systolic/diastolic hypertension comparing Teveten and Ramipril and type 2 Diabetics) |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Essential Hypertension grade I and II |
| Intervention | Single, double- and triple- combination antihypertensive therapy, active controlled (monotherapy [eprosartan versus ramipril] followed by addition of hydrochlorothiazide as second agent and moxonidine as a third agent). |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Investigative centers from eight European countries and Canada (primary and secondary care) targeting patients with grade I - II hypertension and associated diabetes mellitus type 2. Goal blood pressure (BP) targeted: below 130/80 mmHg. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- Germany
Study participating centre
Hans-Boeckler Allee 20
Hannover
30173
Germany
30173
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? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 01/10/2004 | Yes | No |
Editorial Notes
06/07/2018: No publications found, verifying study status with principal investigator
