Clinical trial NCT00350168: Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension
Official title: An 8-week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Blood pressure
Venous pressure
Systolic pressure
Diastolic pressure
Pulse pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-10
Enrollment: 647
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in MSSBP at week 4
Secondary outcomes:
measure: Change from baseline MSSBP after 2 and 8 weeks of treatment
measure: Change from baseline MSDBP after 2, 4 and 8 weeks of treatment
measure: Proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment
measure: Evaluation of safety and tolerability after 8 weeks of treatment
Other outcomes:
Locations:
city: E. Hanover
country: United States
facility: Novartis Pharmaceuticals Corp
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.