Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan plus amlodipine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Sponsor
Summary
This study will evaluate the safety and efficacy of the fixed combination of
valsartan/amlodipine in adult patients with mild to moderate hypertension
Clinical Details
Official title: A Multi-Center, Double Dummy, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5mg to Valsartan 160mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160mg Monotherapy.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Diastolic blood pressure changes at baseline versus endpoint
Secondary outcome: Systolic blood pressure changes from baseline compared to endpointDiastolic and Systolic blood pressure changes at baseline compared to various time points Diastolic and systolic blood pressure response and control rates Safety and tolerability of valsartan 80 mg plus amlodipine 5 mg and valsartan 160 mg alone.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female outpatients >= 18 years and < 86 years
- Patients with essential diastolic hypertension
- At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and
< 10 mmHg; patients treated with antihypertensive medication must have a mean sitting
diastolic blood pressure < 100 mmHg
- At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg
and < 100 mmHg
- At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg
and < 110 mmHg
Exclusion Criteria:
- Severe hypertension >= 180/110 mmHg
- Known or suspected contraindications, including a history of allergy or
hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical
structures
- Inability to discontinue all prior antihypertensive medications safely for a maximum
period of up to 28 days prior to Visit 2
- History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic
attack, myocardial infarction or other types of revascularization
- Malignant hypertension
- All patients with Type I diabetes and those patients with Type 2 diabetes who are not
well controlled based on the investigator's clinical judgment
- Pregnant or nursing women
- History of heart failure
- Angina pectoris
- Second or third degree heart block
- Life threatening or symptomatic arrhythmias
- Clinically significant valvular heart disease
- Evidence of a secondary form of hypertension
- Known or moderate malignant retinopathy
- Evidence of hepatic disease
- Evidence of renal impairment
Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences, Beijing 100020, China
Beijing General Hospital of Beijing Military Region, Beijing 100700, China
Beijing Hospital, Beijing 100730, China
The people's Hospital of Liaoning Province, Shenyang 110016, China
The First Affiliated Hospital of China Medical University, Shenyang 110001, China
Second Hospital of Hebei University of Medical Sciences, Shijiazhuang 050050, China
The People's Hospital of Hebei Provincial, Shijiazhuang 050051, China
Second Military Medical University Affiliated Changzheng Hospital, Shanghai 200003, China
Second Military Medical University Affiliated Changhai Hospital, Shanghai 200433, China
Southeast University Affiliated Zhong Da Hospital, Nanjing 210009, China
The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
The First Affiliated Hospital of Soochow University, Suzhou 215006, China
The Second Affiliated Hospital of Soochow University, Suzhou 215004, China
The First Affiliated Hospital of Medical College of Zhejiang University, Hangzhou 310007, China
The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou 310006, China
The First People's Hospital of Hangzhou, Hangzhou 310006, China
Department of cardiology, Ruijin hospital;, Shanghai 200025, China
Department of cardiology, Ruijin hospital, Shanghai 200025, China
Fudan University affiliated zhongshan hospital, Shanghai 200032, China
Additional Information
Starting date: January 2007
Ending date: December 2007
Last updated: June 9, 2008
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