Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Participation in any clinical investigational drug study within the previous 12 weeks
Concomitant treatments with:
1. Any anti-hypertensive treatment other than Valsartan 80 mg
2. Cytochrome P450-3A4 inhibitors or inducers
3. 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
Clareo Health | Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension
