| December 18, 2006 |
| October 27, 2008 |
| January 2007 |
| November 2007 (final data collection date for primary outcome measure) |
| Diastolic blood pressure changes at baseline versus endpoint (Wk 8) [ Time Frame: Week 8 ] [ Designated as safety issue: No ] |
| Diastolic blood pressure changes at baseline versus endpoint (Wk 8) |
| Complete list of historical versions of study NCT00413049 on ClinicalTrials.gov Archive Site |
- Systolic blood pressure changes from baseline compared to endpoint (Wk 8) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
- Diastolic and systolic blood pressure changes from baseline to various time points [ Time Frame: baseline to various time points ] [ Designated as safety issue: No ]
- Diastolic and systolic blood pressure response and control rates [ Time Frame: during treatment period ] [ Designated as safety issue: No ]
- Safety and tolerability of valsartan 80 mg plus amlodipine 5 mg and amlodipine 5 mg alone. [ Time Frame: during treatment period ] [ Designated as safety issue: No ]
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- 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.
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| |
| Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension |
| 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. |
This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Hypertension |
- Drug: Valsartan plus amlodipine
- Drug: Amlodipine
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| |
| |
| |
| Completed |
| 698 |
|
| November 2007 (final data collection date for primary outcome measure) |
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.
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| Both |
| 18 Years to 85 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| China |
| |
| NCT00413049 |
| Novartis Medical Director, Novartis Pharmaceuticals |
| CVAA489A2315 |
| Novartis |
|
| Study Director: |
Novartis Pharmaceuticals |
Sponsor GmbH |
|
|
| Novartis |
| October 2008 |