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This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Participation in any clinical investigational drug study within the previous 12 weeks
Concomitant treatments with:
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
Primary purpose
Allocation
Interventional model
Masking
360 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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