A double-blind, randomized, multicenter study to evaluate the effectiveness of the combination of valsartan and amlodipine in hypertensive patients not controlled on monotherapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 926

Inclusion Criteria

1.Male or female patients =18 years of age
2.Non-diabetic patients must have MSSBP of =140 mmHg and/or MSDBP =90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP =130 mmHg and/or MSDBP =80 mmHg at Visits 1 and 2
3.Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1
4.Written informed consent to participate in the study prior to any study procedures

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.Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure
2.MSSBP =180 mmHg and/or MSDBP =110 mmHg (MSSBP =160 mmHg and/or MSDBP =100 mmHg for diabetic patients) at any time between Visit 1 and Visit 2.
3.Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma
4.Known Keith-Wagener grade III or IV hypertensive retinopathy
5.History of hypertensive encephalopathy, cerebrovascular accident or myocardial infarction
6.History of transient ischemic attack 12 months prior to Visit 1
7.Percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1
8.Diabetes mellitus type 1
9.Poorly controlled type 2 diabetes mellitus, i.e. glycosylated hemoglobin (HbA1c) >8.0%
10.History of heart failure Grade II - IV according to the NYHA classification
11.Second or third degree heart block without a pacemaker
12.Concomitant unstable angina pectoris
13.Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
14.Clinically significant valvular heart disease
15.Evidence of hepatic disease as determined by one of the following: ALT or AST values >3 x UNL at visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
16.Evidence of renal impairment as determined by one of the followings: serum creatinine >1.5 x UNL at visit 1, a history of dialysis, or a history of nephrotic syndrome
17.Serum sodium value < 135 mmol/L at visit 1
18.Serum potassium values <3.5 mmol/L or >5.5 mmol/L at visit 1
19.Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug
20.Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks post surgical bilateral oophorectomy and/or hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double –barrier methods1 (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
21.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)
22.Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period
23.History of malignancy of any organ system within the past five years, treated or untreated, including leukemia and lymphoma (but not basal cell skin cancer) whether or not there is evidence of local recurrence of metastases
24.Any severe, life-threatening disease within the past five years
25.History of drug or alcohol abuse within the last 2 years
26.Use of

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

Related Trials