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

NCT ID: NCT00350168

Last Updated: 2016-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 647 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-04-30

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 stage II hypertensive patients (MSSBP ≥ 160 mmHg).

Conditions

Hypertension

Study Design

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

Interventions

valsartan + amlodipine

Intervention Type: DRUG

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 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
• 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.

• 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_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals Corp

East Hanover, New Jersey, United States

Countries

United States

References

Destro M, Luckow A, Samson M, Kandra A, Brunel P. Efficacy and safety of amlodipine/valsartan compared with amlodipine monotherapy in patients with stage 2 hypertension: a randomized, double-blind, multicenter study: the EX-EFFeCTS Study. J Am Soc Hypertens. 2008 Jul-Aug;2(4):294-302. doi: 10.1016/j.jash.2008.01.004. Epub 2008 Jun 2.

Reference Type: RESULT

PMID: 20409909 (View on PubMed)

Other Identifiers

CVAA489A2403

Identifier Type: -

Identifier Source: org_study_id