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
Secondary identifying numbers	S171.3.012

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

Dr Cornel Pater
Scientific

Hans-Boeckler Allee 20
Hannover
30173
Germany

Phone	+49 (0)511 857 2074
Email	cornel.pater@solvay.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2004
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

Hans-Boeckler Allee 20

Hannover
30173
Germany

Solvay Pharmaceuticals (Germany)
Industry

Hans-Boeckler Allee 20
Hannover
30173
Germany

"ROR"	https://ror.org/01xscrc43

Industry

GPS Solvay Pharmaceuticals

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	01/10/2004		Yes	No

06/07/2018: No publications found, verifying study status with principal investigator