Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension

Inclusion criteria

• Men and women aged 18 - 75 years
• Essential hypertension not well controlled by current low dose (80 mg) valsartan monotherapy for at least 4 weeks. Patients on prior treatment with monotherapy diuretic, ACE-I or beta blocker or an ARB other than valsartan and switched to the current low dose valsartan 80 mg monotherapy for at least 4 weeks are also eligible, provided the hypertension is still not well controlled.
• Office systolic blood pressure (sitting) >140 mmHg (sitting for >/= 5 min., no cigarettes and/or coffee/tea for >/=30 min. before BP measurement).
• BMI <33 kg/m2

Exclusion criteria

• Participation in any clinical investigational drug study within the previous 12 weeks
• Concomitant treatments with:

• Any anti-hypertensive treatment other than Valsartan 80 mg
• Cytochrome P450-3A4 inhibitors or inducers
• Potassium-sparing diuretics
• Severe hypertension (DBP >/= 110 mm Hg and/or SBP >/= 180 mm Hg) and/or evidence of secondary forms of hypertension
• Any of the following cardiovascular diseases:
• History of cardiovascular shock
• Myocardial infarction or unstable angina within the previous 6 months
• Severe cardiac valve disease
• Past or present severe rhythm or conduction disorder.
• Cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (SAH) within the previous 12 months
• Type 1 or 2 diabetes mellitus
• Proteinuria
• Uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia
• Gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)
• Cholestasis or biliary obstruction
• Liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels >3 x upper limits of normal (ULN)
• Renal failure, creatinine level >2.0 mg/dl