| February 16, 2007 |
| January 27, 2009 |
| January 2007 |
| November 2007 (final data collection date for primary outcome measure) |
- Change in mean sitting systolic blood pressure (MSSBP) [ Time Frame: after 8-week treatment ] [ Designated as safety issue: No ]
- Incidence of peripheral edema quantified as adverse event (AE) reported peripheral edema [ Time Frame: after 8-week treatment ] [ Designated as safety issue: Yes ]
|
- Change in mean sitting systolic blood pressure (MSSBP) after 8-week treatment
- Incidence of peripheral edema quantified as adverse event (AE) reported peripheral edema after 8-week treatment
|
| Complete list of historical versions of study NCT00437645 on ClinicalTrials.gov Archive Site |
- Change in mean sitting diastolic blood pressure (MSDBP) [ Time Frame: after 8-week treatment ] [ Designated as safety issue: Yes ]
- Change from baseline in MSSBP and MSDBP [ Time Frame: after 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
- Systolic blood pressure responder rate (defined as MSSBP < 130 mmHg or ≥ 20 mmHg reduction from baseline) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]
- Proportion of patients who reach systolic blood pressure control (defined as MSSBP < 130mmHg) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]
- Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]
|
- Change in mean sitting diastolic blood pressure (MSDBP) after 8-week treatment
- Change from baseline in MSSBP and MSDBP after 4 and 12 weeks of treatment
- Systolic blood pressure responder rate (defined as MSSBP < 130 mmHg or ≥ 20 mmHg reduction from baseline) at week 4, 8, and 12
- Proportion of patients who reach systolic blood pressure control (defined as MSSBP < 130mmHg) at week 4, 8, and 12
- Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) at week 4, 8, and 12
|
| |
| Safety and Efficacy of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension |
| A Double-Blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of Treatment With the Combination of Valsartan/Amlodipine 160/5 mg Compared to Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Alone |
This study is designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled [defined as mean sitting systolic blood pressure (MSSBP) ≥ 130 mmHg and ≤ 160 mmHg] on amlodipine 5 mg alone.
The study will evaluate the efficacy and tolerability of both treatment groups by providing data evaluating blood pressure lowering efficacy and the proportion of patients developing peripheral edema. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Essential Hypertension |
- Drug: Valsartan/Amlodipine
- Drug: Amlodipine
|
| |
| Schrader J, Salvetti A, Calvo C, Akpinar E, Keeling L, Weisskopf M, Brunel P. The combination of amlodipine/valsartan 5/160 mg produces less peripheral oedema than amlodipine 10 mg in hypertensive patients not adequately controlled with amlodipine 5 mg. Int J Clin Pract. 2009 Feb;63(2):217-25. |
| |
| Completed |
| 1183 |
| November 2007 |
| November 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male or female outpatients ≥ 55 years of age
- Patients with essential hypertension measured using a validated automated oscillometric device at Visit 1
- Non-treated patients must have a MSSBP ≥140 mmHg and ≤ 160 mmHg
- Patients pre-treated on monotherapy prior to Visit 1 must have MSSBP ≤ 160 mmHg
- To be eligible for randomization at Visit 2 (Day 1) all patients must have a MSSBP ≥130 mmHg and ≤ 160 mmHg
- No peripheral edema at Visit 2 (randomization)
- Written informed consent to participate in this study prior to any study procedures
Exclusion Criteria:
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
- Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures
- Patients taking more than 1 antihypertensive medication at Visit 1
- Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of pre-treated patients that require tapering down of anti-hypertensive treatments. For patients with previous antihypertensive medication that require a gradual downward titration, the tapering down should be done according to manufacturers instructions and last dose should be taken by week -2 prior to randomization
- MSSBP >180mmHg or MSDBP >110 mmHg at any time between Visit 1 and Visit 2
- Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, polycystic kidney disease, or pheochromocytoma
- History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1
- History of heart failure Grade II - IV according to the NYHA classification
- Second or third degree heart block with or without a pacemaker
- Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
- Concomitant unstable angina pectoris
- Clinically significant valvular heart disease
- Patients with Type 1 diabetes mellitus
- Patients with Type 2 diabetes mellitus who are not well controlled based on the investigator's judgment. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1.
Other protocol-defined inclusion/exclusion criteria may apply. |
| Both |
| 55 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Finland, Germany |
| |
| NCT00437645 |
| Novartis Pharmaceuticals, External Affairs |
| CVAA489A2404 |
| Novartis Pharmaceuticals |
|
| Study Chair: |
Novartis Pharmaceuticals |
Novartis Pharmaceuticals |
|
|
| Novartis |
| January 2009 |