efficacy and safety of valsartan and amlodipine in patients with essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. the study will investigate the dose response relationship for the combinations, monotherapies, and placebo.


Eligibility criteria:
inclusion criteria * patients with essential hypertension measured by electronic hemodynamometer. - - patients must satisfy the following criteria. 1. msdbp \<110 mmhg and mssbp \<180 mmhg at visit 1 2. msdbp ≥ 90 mmhg and \< 110 mmhg and mssbp \< 180 mmhg at visit 2 3. msdbp ≥ 95 mmhg and \< 110 mmhg and mssbp \< 180 mmhg at visit 3 4. the absolute difference in msdbp between visit 2 and 3 is ≤ 10 mmhg * male or female outpatients. * aged =\> 20 and =\< 80 years (at the time of signing informed consent). * patients who have written informed consent to participate in this study. exclusion criteria * pregnant women, nursing (lactating) mothers, women suspected of being pregnant, or women who wish to be pregnant during the study, women of child-bearing potential. * patients with secondary hypertension or suspected of having secondary hypertension. * patients with a history of malignant hypertension. * patients with an inability to completely discontinue all prior antihypertensive medications safely for a period of 12 weeks as required by the protocol. * patients with or with a history of any of the following diseases or signs: cardiac disease, renal disease, cerebrovascular disorder * patients with a clinically significant allergy (asthma on pharmacotherapy, multi-drug allergy, or drug-induced or food-induced anaphylactic reactions). * patients hypersensitive to aii receptor antagonists, calcium channel blockers or dihydropyridine derivatives. * known moderate or malignant retinopathy. * patients with or with a history of pancreatitis. patients with pancreatic injury, or evidence of impaired pancreatic function/injury within 12 months of visit 1. * patients with any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. * patients with volume depletion based on the investigator's or subinvestigator's clinical judgment using vital signs, skin turgor, moistness of mucous membrane and laboratory values. * patients who are found to have low na and k (na \<130 meq/l, k \<3.3meq/l) or high in these parameters (na ≥ 152 meq/l, k ≥ 5.2 meq/l) by laboratory tests at visit 1. * patients with type i diabetes mellitus on treatment with insulin, or patients with type ii diabetes with poor glucose control defined as a glycosylated hemoglobin (hba1c) \> 8.0% at visit 1. * patients with or with a history of malignant tumors including leukemia and lymphoma, treated or untreated, within the past 5 years of visit 1 whether or not there is evidence of local recurrence or metastases (except for localized basal cell carcinoma of the skin). * patients with any severe, life-threatening disease within the past 5 years. patients with a history of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. * any surgical or medical condition, which in the opinion of the investigator or subinvestigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirement of the study or completing the trial period. * patients who have with or with a history of drug or alcohol abuse within the last 2 years of visit 1. patients who have received other investigational product within 12 weeks of visit 1. * any chronic inflammatory condition needing chronic anti-inflammatory drug therapy. * persons directly involved in the execution of this study. * patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or subinvestigator.

Keywords: hypertension, valsartan, amlodipine, high blood pressure