Clinical trial NCT00425373 (phase 2/phase 3, status: completed)
Conditions: essential hypertension
ICD codes: I10, O10.02, O10.03, O10.011, O10.012, O10.013, O10.019
Drugs: valsartan + amlodipine 40/2.5 mg, valsartan + amlodipine 40/5 mg, valsartan + amlodipine 80/2.5 mg, valsartan + amlodipine 80/5 mg, valsartan 40 mg, valsartan 80 mg, amlodipine 2.5 mg, amlodipine 5 mg, placebo
SMILES: CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O, CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O, CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O, CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O, CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O, OC(CNCC(O)C1CCC2=C(O1)C=CC(F)=C2)C1CCC2=C(O1)C=CC(F)=C2, CCOC(=O)C1=C(COCCN)NC(C)=C(C1C1=CC=CC=C1Cl)C(=O)OC, CCOC(=O)C1=C(COCCN)NC(C)=C(C1C1=CC=CC=C1Cl)C(=O)OC, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.