A randomized, open-label, multicenter, cross-over trial to evaluate the efficacy of a 20 week treatment of Valsartan 320 mg (Diovan) versus Atenolol 100 mg in combination with Hydrochlorothiazide on microcirculation in hypertensive patients - DIVINATIO

• Conditions: Essential mild-to-moderate hypertension; MedDRA version: M15Level: LLTClassification code 10020772

• Registration Number: EUCTR2005-003958-94-DE
• Lead Sponsor: ovartis Phama GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-29
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.
2. Diagnosed at Visit 1 to be mild-to-moderate hypertensive with a MSDBP =95 mm Hg and < 110 mm Hg for non treated patients. Previously treated patients should have a MSDBP <110 mmHg at Visit 1. Treated is defined as having taken medication until = 2 days prior to Visit 1.
3. At Visit 2 all patients must have a MSDBP = 90 mmHg and < 110 mmHg.
4. Written informed consent to participate in the study prior to any study procedures.
5. Ability to communicate and comply with all study requirements.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.If a single reading for arterial hypertension in MSSBP > 180 mm Hg or MSDBP of > 110 mm Hg at any visit after randomization.
2. Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.
3. Known history of hypotensive symptoms or orthostatic hypotension.
4. Concomitant use of statins or statin intake during the four weeks prior to Visit 1.
5. Known or suspected contraindications as listed in the basic prescribing information, including history of hypersensitivity to any of the study drugs (valsartan, atenolol and HCTZ) or to drugs with similar chemical structures or to inactive ingredients of valsartan film-coated tablets, atenolol or hydrochlorothiazide tablets.
6. Known Keith-Wagener grade III or IV hypertensive retinopathy.
7. Concurrent life threatening arrhythmia or symptomatic arrhythmia.
8. History of secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing’s disease, pheochromocytoma, polycystic kidney disease, etc..
9. A history of stroke, transient ischemic cerebral attack, hypertensive encephalopathy, coronary artery bypass surgery, percutaneous transluminal angioplasty or myocardial infarction anytime prior to visit 1.
10. A history of heart failure (NYHA II-IV).
11. Second or third degree heart block, sick sinus syndrome or sinuatrial block.
12. Bradycardia at Visit 1, defined as < 50 beats per minute.
13. Acidosis.
14. Shock
15. Hypovolaemia
16. History of bronchial hypersensitivity e.g. asthma bronchiale.
17. Any form of clinically significant peripheral circulatory disturbances.
18. Clinically significant valvular heart disease.
19. Concomitant unstable angina pectoris
20. Evidence of renal impairment as determined by one of the following: Serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault formula [Cockroft and Gault, 1976], serum creatinine > 1.5 mg/dL at Visit 1, a history of dialysis, history of nephritic syndrome, acute glomerulonephritis, kidney donor or kidney recipient.
21. Insulin dependent Diabetes mellitus.
22. Uncontrolled treated Type 2 Diabetes mellitus with poor glucose control defined as HbA1c > 7.0 % at Visit 1.
23. Evidence of hepatic disease or cholestasis as determined by any one of the following: ALT (SGPT) or AST (SGOT) values >2 x upper limit of normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
24. Gout or known history of recurrent clinical significant hyperuricaemia
25. Serum potassium <3.5 mmol/l or >5.5 mmol/l at Visit 1.
26. Serum sodium < 132mmol/L or > 150 mmol/L at Visit 1.
27. Hypercalcaemia >2.7 mmol/l.

Further exclusion criteria are defined in the study protocol.

Study & Design

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