Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients

NCT ID: NCT00409643

Last Updated: 2011-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2004-07-31

Brief Summary

This trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

valsartan+amlodipine combination

Intervention Type: DRUG

valsartan

Intervention Type: DRUG

amlodipine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Outpatients 18 years and older.
• Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed.
• Patients with essential diastolic hypertension measured by calibrated standard aneroid or mercury (preferable) sphygmomanometer. Patients must have a MSDBP > 90 mmHg and < 110 mmHg at Visit 1 (week -4 to -2), and a MSDBP > 95 mmHg and < 110 mmHg at Visit 2 (week 0).
• Patients must have an absolute difference of > 10 mmHg in their average sitting diastolic blood pressure between Visits 1 and 2.
• Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria

• Severe hypertension (MSDBP 110 mmHg and/or MSSBP 180 mmHg) at anytime.
• Inability to discontinue all prior antihypertensive medications safely for a period of 14 weeks.
• Known Keith-Wagener grade III or IV hypertensive retinopathy.
• History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 0 (week -6 to -4).
• Transient ischemic cerebral attack during the last 12 months prior to Visit 0 (week -6 to -4).
• Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing Disease, pheochromocytoma, polycystic kidney disease etc.
• Type 1 diabetes mellitus.
• Type 2 diabetes mellitus with poor glucose control as defined by fasting glycosylated hemoglobin (HbA1c) >8% at Visit 1 (week -4 to -2).
• Administration of any agent indicated for the treatment of hypertension within a minimum 4 weeks prior to randomization into the study (Visit 2, week 0), with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 0 (week -6 to -4).
• Known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis pharmaceuticals

Role: STUDY_CHAIR

Sponsor GmbH

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Sites in Germany

Germany, , Germany

Countries

United States; Germany

Other Identifiers

CVAA489A2307

Identifier Type: -

Identifier Source: org_study_id