Essential mild-to-moderate hypertension MedDRA version: M15 Level: LLT Classification code 10020772
Conditions
Interventions
Trade Name: Diovan 160mg Filmtabletten
Product Name: Diovan 160mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valsartan
Current Sponsor code: VAH631
Concentration unit:
Sponsors
Novartis Phama GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 5.5 mmol/l at Visit 1. 26. Serum sodium 150 mmol/L at Visit 1. 27. Hypercalcaemia >2.7 mmol/l. Further exclusion criteria are defined in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that valsartan (320 mg o.d.) has superior efficacy compared to atenolol (100 mg o.d.) in combination with hydrochlorothiazide (HCTZ) (12.5 mg o.d.) in improving microcirculation in terms of mean post-treatment absolute perfusion units [PU] measure by Laser Dopppler,following intradermal application of three different concentrations of acetylcholine (ACH) in patients with mild to moderate essential hypertension.;Secondary Objective: 1. To evaluate whether valsartan has superior efficacy compared to atenolol/HCTZ in improving microcirculation in terms of mean post-treatment absolute PUs following intradermal application of three different concentrations of acetylcholine in the presence of L-NMMA. 2. To demonstrate the effect of valsartan or atenolol/HCTZ treatment on the vascular responses to individual dosages of provocation test substances such as ACH with or without L-NMMA, L-NMMA alone and Sodium nitroprusside (SNP). 3. To evaluate whether valsartan has superior efficacy compared to atenolol/HCTZ in improving microcirculation in terms of post-treatment absolute PUs following intradermal application of a sodium chloride solution. 4. To demonstrate that valsartan has superior efficacy compared to atenolol/HCTZ in reducing the large artery stiffness and pulse wave reflection measured as the decrease in augmentation index, central aortic blood pressure and pulse wave velocity. 5. Safety and tolerability ;Primary end point(s): The primary variable is the post-treatment microcirculation measured by Laser Doppler Imager scanner (LDI scanner) in perfusion units [PU] relative to NaCl. The microcirculation is calculated in the following way: for the three different concentrations of ACH as well as for the NaCl-control, 12 measurements each will be done at 2, 4.5, 7, 9.5,..., 29.5 minutes post injection. Then the mean over these 12 measurements will be taken and the difference to the NaCl-control will be calculated. The primary endpoint is th | — |
Countries
Germany
Outcome results
None listed