Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
NCT ID: NCT01001572
Last Updated: 2011-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
932 participants
INTERVENTIONAL
2009-09-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Valsartan 160 mg
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Valsartan 160 mg
Valsartan 160 mg capsule taken orally once daily.
Placebo
1 capsule or tablet taken orally once daily
Valsartan/amlodipine 160/5 mg
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks
Valsartan/amlodipine 160/5 mg
Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.
Placebo
1 capsule or tablet taken orally once daily
Single-Blind Run-In Valsartan 160 mg
Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
Valsartan 160 mg
Valsartan 160 mg capsule taken orally once daily.
Interventions
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Valsartan/amlodipine 160/5 mg
Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.
Valsartan 160 mg
Valsartan 160 mg capsule taken orally once daily.
Placebo
1 capsule or tablet taken orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female ages 18 or older and less than 86 years
* Diagnosed as having essential diastolic hypertension, as follows:
* Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and \< 100 mmHg
* At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP \>=90 mmHg and \<110 mmHg
Exclusion Criteria
* Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
* Malignant hypertension
* Administration of any agent indicated for the treatment of hypertension after Visit 1
* Known moderate or malignant retinopathy.
* Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
* History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
* History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
* Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
18 Years
85 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Investigative site in Romainia
, ,
Novartis Investigative Site
, ,
Countries
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Other Identifiers
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CVAA489A2317
Identifier Type: -
Identifier Source: org_study_id
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