Efficacy & Safety of Orally Administered Valsartan/Amlodi... | NCT00353912

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

NCT00353912

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 18, 2016Estimated

Enrollment

571Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

valsartan + amlodipine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Jul 17, 2006

First Submission Date that Met QC Criteria

Jul 17, 2006

First Posted Date

Jul 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2016

Last Update Posted Date

Nov 18, 2016Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

571Actual

Name	Type	Description	Arm Group Labels	Other Names
valsartan + amlodipine	Drug

Measure	Description	Time Frame
Change from baseline in MSSBP at week 8

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		East Hanover	New Jersey	07936	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19190658	Result	Flack JM, Calhoun DA, Satlin L, Barbier M, Hilkert R, Brunel P. Efficacy and safety of initial combination therapy with amlodipine/valsartan compared with amlodipine monotherapy in black patients with stage 2 hypertension: the EX-STAND study. J Hum Hypertens. 2009 Jul;23(7):479-89. doi: 10.1038/jhh.2008.153. Epub 2009 Jan 29.

ID	Term
D006973	Hypertension
D054160	Systolic Murmurs
D006337	Heart Murmurs

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000068756	Valsartan
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Measure	Description	Time Frame
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