Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00353912
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of Black stage II hypertensive patients (MSSBP ≥ 160 mmHg).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-19
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 571

Inclusion Criteria

• 18 years of age or older.
• Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.

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Exclusion Criteria

• History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
• Inability to stop all prior blood pressure medications safely
• Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
• Controlled blood pressure (systolic BP < 140 mmHg) taking more than 3 antihypertensive medications at screening
• Systolic BP ≥ 140 mmHg and < 180 mmHg taking more than two antihypertensive medications at screening
• Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
• History of autoimmune diseases
• History of multiple drug allergies
• Liver disease
• Pancreatic injury within 1 year of screening
• Evidence of kidney impairment or history of dialysis
• Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.
• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
• Pregnant or nursing (lactating) women
• History of malignancy of any organ system within the past five years
• Any severe, life-threatening disease within the past five years
• History of drug or alcohol abuse within the last 2 years.
• History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
• Type 1 diabetes
• Poorly controlled Type 2 diabetes
• History of heart failure
• Arrhythmia
• Significant valvular heart disease
• Active gout

Other protocol-defined inclusion/exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in MSSBP at week 8

Secondary Outcome Measures

Name	Time	Method
evaluation of safety and tolerability after 12 weeks of treatment
change from baseline MSDBP after 2, 4, 8 and 12 weeks of treatment
change from baseline MSSBP after 2, 4 and 12 weeks of treatment
proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 12 weeks of treatment

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 E. Hanover, New Jersey, United States