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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00353912

First received: July 17, 2006

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2006

Last Updated Date

November 7, 2011

Start Date ^ICMJE

June 2006

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in MSSBP at week 8

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00353912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A 12-week, Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combo Based Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: valsartan + amlodipine

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

571

Completion Date

April 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00353912

Other Study ID Numbers ^ICMJE

CVAA489A2402

Has Data Monitoring Committee

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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