A multicenter, double-blind, randomized study comparing the efficacy of combination therapy of Eprosartan respectively Ramipril with low-dose Hydrochlorothiazide and Moxonidine on blood pressure levels in patients with hypertension and associated diabetes mellitus type 2 (ASTRID – Antihypertensive treatment of Systolic/diastolic hypertension comparing Teveten and Ramipril in type 2 Diabetics). - ASTRID

Active, not recruiting

• Conditions: Essential hypertension with associated Diabetes Mellitus type 2.

• Registration Number: EUCTR2004-000703-18-ES
• Lead Sponsor: SOLVAY PHARMACEUTICALS GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1. Males and females aged 40 to 80 years of age (inclusive).
A female of child-bearing potential may be enrolled provided that she:
- is routinely using adequate hormonal contraception, either in a depot
or oral formulation at a stable dose for at least three months prior to the
start of the treatment or a barrier method (intrauterine device, diaphragm,
combination of condom and spermicide) prior to and during the trial and
- is not breast feeding and
- agrees not to attempt to become pregnant during the trial.
A female of non-childbearing potential may be enrolled in the study, and will
be defined as one who has been postmenopausal for at least 24 months,
has been surgically sterilized (i.e. tubal ligation) or had a hysterectomy prior
to the screening phase.

2. Eligible patients should have diagnosed essential hypertension (not controlled with
current treatment, i.e., BP = 130/80 - = 179/109 mmHg) and diagnosed associated
diabetes mellitus type 2, willing to accept withdrawal of any antihypertensive
medication by the time of the Screening visit.

3. Patients have given and signed informed consent by visit V0.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Grade 3 hypertension (systolic BP = 180 mmHg and/or diastolic BP = 110 mmHg).
2. Symptoms of orthostatic hypotension or supine systolic BP = 90 mmHg.
3. Secondary forms of hypertension including, but not limited to, coarctation of aorta,
primary aldosteronism, pheochromocytoma, or due to current use of hormonal
contraceptive agents.
4. Any form of rhythm or conduction abnormality requiring therapy.
5. Clinically significant heart failure (NYHA class III and IV) or in need of treatment
with ACE inhibitors or diuretics.
6. Signs, symptoms, or history of myocardial infarction or cerebrovascular accident
during the past three months.
7. Any form of angina pectoris requiring therapy.
8. Severe obstructive airway disease with permanent respiratory insufficiency.
9. Diabetic mellitus type 1 and subjects with HbA1c > 8.5%.
10. Creatinine > 2 x upper normal limit.
11. SGOT or SGPT > 2 x upper normal limit.
12. Presence of any condition which limits life expectancy (cancer, haematological
diseases, etc.).
13. Problems with compliance or follow-up anticipated.
14. Participation in another trial or study within the past 30 days.
15. Pregnancy and lactation.
16. Known hypersensitivity to ingredients of Eprosartan, Ramipril, Hydrochlorothiazide or Moxonidine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified