Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80 mg Monotherapy.
1 other identifier
interventional
1,134
1 country
19
Brief Summary
This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Jan 2007
Shorter than P25 for phase_3 hypertension
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
September 14, 2009
CompletedApril 28, 2011
April 1, 2011
10 months
December 18, 2006
August 6, 2009
April 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Baseline to end of study (Week 8)
Secondary Outcomes (4)
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
Baseline to end of study (Week 8)
Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)
Baseline to end of study (Week 8)
Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)
End of study (Week 8)
Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
End of study (Week 8)
Study Arms (3)
Valsartan/amlodipine 80/5 mg
EXPERIMENTALValsartan 80 mg
ACTIVE COMPARATORValsartan 160 mg
ACTIVE COMPARATORInterventions
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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 First People's Hospital of Hangzhou
Hangzhou, 310006, China
The Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, 310006, China
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, 310007, China
Southeast University Affiliated Zhong Da Hospital
Nanjing, 210009, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029, China
Second Military Medical University Affiliated Changzheng Hospital
Shanghai, 200003, 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
Second Military Medical University Affiliated Changhai Hospital
Shanghai, 200433, China
The First Affiliated Hospital of China Medical University
Shenyang, 110001, China
The people's Hospital of Liaoning Province
Shenyang, 110016, China
Second Hospital of Hebei University of Medical Sciences
Shijiazhuang, 050050, China
The People's Hospital of Hebei Provincial
Shijiazhuang, 050051, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 18, 2006
First Posted
December 19, 2006
Study Start
January 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
April 28, 2011
Results First Posted
September 14, 2009
Record last verified: 2011-04