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 hypertension

ovartis Pharma Services AG0 sites2,252 target enrollmentApril 13, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Pharma Services AG
Enrollment: 2252
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 13, 2006

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

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
•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

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.