Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Amlodipine/Valsartan (Drug); Amlodipine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: 41.61.324.1111
Summary
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80
mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and
amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential
hypertension. All three regimens are expected to be well tolerated.
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The overall reporting of adverse events, serious adverse events (SAEs) including death, discontinuation due to adverse events, and notable laboratory abnormalities.
Secondary outcome: To evaluate: aml/val 5/80mg compared to aml 5 mg monotherapy,To evaluate aml/val 5/40mg to aml 5 mg monotherapy To evaluate blood pressure lowering effects To evaluate changes in orthostatic blood pressure, sitting and standing pulse, and laboratory data
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must give written informed consent before any assessment is performed.
- Male or female ages 65 years and older.
- Diagnosed as having hypertension:
- Visit 3/Core double-blind treatment period entry, all patients MUST have a mean
seated SBP ≥145 mmHg and <180 mmHg.
- Ability to communicate and comply with all study requirements including measuring
their blood pressure at home, daily as instructed, using the home blood pressure
monitor provided by the Sponsor.
- Female patients must be post-menopausal for at least one year.
Exclusion Criteria:
- Patients with severe hypertension (mean seated SBP ≥180 mmHg and/or a mean seated DBP
≥110 mmHg).
- Patients who have a history of secondary hypertension (including primary
aldosteronism, renovascular hypertension, pheochromocytoma, etc.).
- Patients receiving three or more antihypertensive drugs. Dual fixed dose combination
therapy will be considered as two antihypertensive drugs.
- Administration of any agent indicated for the treatment of hypertension after Visit
1, with the permitted exception of those antihypertensive medications requiring
tapering down (e. g. beta-blocker and/or clonidine) commencing with Visit 1.
- Known moderate or malignant retinopathy. Moderate defined as: retinal signs of
hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof;
malignant defined as: signs of moderate retinopathy plus swelling of the optic disk.
- Known or suspected contraindications, including history of allergy or
hypersensitivity to ARBs, CCBs, or to drugs with similar chemical structures.
- History of cerebrovascular accident, thrombotic stroke, or transient ischemic attack.
- Significant history of coronary artery disease (CAD) such as any history of
myocardial infarction (MI), angina pectoris, and all types of revascularization
procedures.
Other protocol-defined inclusion/exclusion criteria may apply" at the end of this section
Locations and Contacts
Novartis Pharmaceuticals, Phone: 41.61.324.1111
Novartis Investigative site, Brno, Czech Republic; Recruiting
Novartis Pharmaceuticals, Phone: 41.61.324.1111
Investigative sites Czech Republic, Praha, Czech Republic; Recruiting
Novartis Pharmaceuticals, Phone: 41.61.324.1111
Investigative sites Czech Repbulic, Hodonin, Czech Republic; Recruiting
Novartis Pharmaceuticals, Phone: 41.61.324.1111
Sites in Czech Republic, Nachod, Czech Republic; Recruiting
novartis pharma, Phone: 41.61.324.1111
Investigative site Czech Republic, Chrudim, Czech Republic; Recruiting
Novartis pharma, Phone: 41.61.324.1111
Investigative site Czech Repbulic, Jicin, Czech Republic; Recruiting
novartis Pharma, Phone: 41.61.324.1111
Investigative site Finland, Joensuu, Finland; Recruiting
Novartis pharma, Phone: 41.61.324.1111
Investigative site Finland, Tampere, Finland; Recruiting
Novartis Pharma, Phone: 41.61.324.1111
Investigative site Finland, Kerava, Finland; Recruiting
Novartis Pharma
Investigative site Finland, Helsinki, Finland; Recruiting
Novartis Pharma, Phone: 41.61.324.1111
Investigative site France, Paris, France; Not yet recruiting
Investigative site Germany, Berlin, Germany; Not yet recruiting
Novartis Pharma, Phone: 41.61.324.1111
Investigative site Hungary, Budapest, Hungary; Recruiting
Novartis Pharma, Phone: 41.61.324.1111
Investigative site Italy, Rome, Italy; Recruiting
Novartis Pharma, Phone: 41.61.324.1111
Investigative site Poland, Warsaw, Poland; Not yet recruiting
Novartis pharma, Phone: 41.61.324.1111
Investigative site Slovakia, Bratislava, Slovakia; Recruiting
Novartis Pharma, Phone: 41.61.324.1111
Investigative site Spain, Valencia, Spain; Recruiting
Novartis pharma, Phone: 41.61.324.1111
Investigative site Sweden, Malmo, Sweden; Not yet recruiting
Novartis pharma, Phone: 41.61.324.1111
Additional Information
Starting date: May 2008
Ending date: June 2009
Last updated: December 16, 2008
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