An 8-week, multicenter, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of the combination of valsartan/HCTZ/amlodipine compared to valsartan/HCTZ, valsartan/amlodipine, and HCTZ/amlodipine in patients with moderate to severe hypertensio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2252

Inclusion Criteria

1.Male or female patients = 18 years and < 86 years of age are eligible.
2.Systolic and diastolic blood pressure requirements:
•Diagnosis of moderate to severe hypertension (MSDBP = 100 mmHg and < 120 mmHg, MSSBP = 145 mmHg and < 200 mmHg) at Visit 3
•Patients must also meet the blood pressure requirements (MSDBP = 95 mmHg and < 110 mmHg, MSSBP < 180 mmHg) at Visit 2
or
•MSDBP = 110 mmHg and < 120 mmHg, and MSSBP = 145 mmHg and < 200 mmHg, or MSDBP = 100 mmHg and < 110 mmHg and MSSBP = 180 mmHg and < 200 mmHg after one week of treatment with placebo (blood pressure check) or at any subsequent scheduled study visit or blood pressure evaluation during the single-blind run-in period (designated Visit 3)
3.Written informed consent to participate in the study prior to any study procedures.
4.Ability to communicate and comply with all study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Inability to discontinue all prior antihypertensive medications safely for a period of 1 to 5 weeks as required by the protocol.
2.Patients with an MSSBP = 180 mmHg and MSDBP < 100 mmHg at any time between one week (7 ± 3 days) and four weeks of treatment with placebo must be discontinued from the study.
3.Patients on two or more antihypertensive drugs with MSSBP = 180 mmHg and/or MSDBP = 110 mmHg at Visit 1 (see Table 4-2).
4.Patients on three or more antihypertensive drugs with MSDBP = 90 mmHg and < 110 mmHg, and/or MSSBP = 140 mmHg and < 180 mmHg at Visit 1(see Table 4-2).
5.Patients on four or more antihypertensive drugs at Visit 1 (see Table 4-2).
6.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml).
7.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
•Hormonal contraceptive use is disallowed.
8.Known moderate or malignant retinopathy. Defined as: moderate (retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof) or malignant (signs of moderate retinopathy plus swelling of the optic disk).
9.Any history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack.
10.Any history of myocardial infarction or all types of revascularization procedures.
11.Heart failure requiring treatment.
12.Second or third degree heart block with or without a pacemaker.
13.Angina pectoris of any type.
14.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
15.Clinically significant valvular heart disease.
16.Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing disease, pheochromocytoma, polycystic kidney disease.
17.All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who are not well controlled based on the Investigator’s clinical judgement. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1.
18.Any condition, not identified in the protocol, that in the opinion of the Investigator or the Novartis monitor, places the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the trial period.
19.Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those antihypertensive medications requirin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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