Clinical trial NCT00413413: Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, valsartan, amlodipine, high blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 1134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.


Eligibility 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.

Primary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
measure: Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
measure: Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)
timeFrame: End of study (Week 8)
measure: Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
timeFrame: End of study (Week 8)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences
city: Beijing
country: China
facility: Beijing General Hospital of Beijing Military Region
city: Beijing
country: China
facility: Beijing Hospital
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Medical College of Zhejiang University
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical College of Zhejiang University
city: Nanjing
country: China
facility: Southeast University Affiliated Zhong Da Hospital
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
city: Shanghai
country: China
facility: Second Military Medical University Affiliated Changzheng Hospital
city: Shanghai
country: China
facility: Department of cardiology, Ruijin hospital;
city: Shanghai
country: China
facility: Department of cardiology, Ruijin hospital
city: Shanghai
country: China
facility: Fudan University affiliated zhongshan hospital
city: Shanghai
country: China
facility: Second Military Medical University Affiliated Changhai Hospital
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
city: Shenyang
country: China
facility: The people's Hospital of Liaoning Province
city: Shijiazhuang
country: China
facility: Second Hospital of Hebei University of Medical Sciences
city: Shijiazhuang
country: China
facility: The People's Hospital of Hebei Provincial
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: