Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amlodipine; Valsartan

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.