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 Amlodipine 5mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5mg Monotherapy.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Diastolic blood pressure changes at baseline versus endpoint (Wk 8)
Secondary outcome: Systolic blood pressure changes from baseline compared to endpoint (Wk 8)Diastolic and systolic blood pressure changes from baseline 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 amlodipine 5 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
Zhongshan hospital affiliated Fudan University, Shanghai 200032, China
People's hospital affiliated Beijing University, Beijing 100044, China
The first hospital affiliated Fujian medical University, Fuzhou 350005, China
Union hospital affiliated Fujian medical University, Fuzhou 350001, China
The second hospital affiliated Jiangxi medical school, Nanchang 330006, China
The third Xiangya hospital of central south University, Changsha 410003, China
The first hospital affiliated the third military Medical University, Chongqing 400038, China
The third hospital affiliated the third military Medical University, Chongqing 400042, China
The first hospital affiliated school of medical of Xi'an Jiaotong University, Xi'an 710061, China
The sixth people's hospital of Shanghai, Shanghai 200233, China
Institute of Hypertension, Ruijin Hospital, Shanghai 200025, China
China-Japan Friendship Hospital, Beijing 100029, China
Additional Information
Starting date: January 2007
Ending date: November 2007
Last updated: June 9, 2008
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