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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
This study has been completed.
First Received: June 9, 2008   Last Updated: February 6, 2010   History of Changes
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00699192
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Amlodipine/Valsartan
Drug: Amlodipine
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The overall reporting of adverse events, serious adverse events (SAEs) including death, discontinuation due to adverse events, and notable laboratory abnormalities. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate: aml/val 5/80mg compared to aml 5 mg monotherapy, [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate aml/val 5/40mg to aml 5 mg monotherapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate blood pressure lowering effects [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate changes in orthostatic blood pressure, sitting and standing pulse, and laboratory data [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 670
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amlodipine/Valsartan 5/80 mg: Experimental Drug: Amlodipine/Valsartan
Amlodipine/Valsartan 5/40 mg: Active Comparator Drug: Amlodipine/Valsartan
Amlodipine 5 mg: Active Comparator Drug: Amlodipine

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699192

Locations
Czech Republic
Novartis Investigative site
Brno, Czech Republic
Investigative sites Czech Republic
Praha, Czech Republic
Investigative sites Czech Repbulic
Hodonin, Czech Republic
Sites in Czech Republic
Nachod, Czech Republic
Investigative site Czech Republic
Chrudim, Czech Republic
Investigative site Czech Repbulic
Jicin, Czech Republic
Finland
Investigative site Finland
Joensuu, Finland
Investigative site Finland
Tampere, Finland
Investigative site Finland
Kerava, Finland
Investigative site Finland
Helsinki, Finland
France
Investigative site France
Paris, France
Germany
Investigative site Germany
Berlin, Germany
Hungary
Investigative site Hungary
Budapest, Hungary
Italy
Investigative site Italy
Rome, Italy
Poland
Investigative site Poland
Warsaw, Poland
Slovakia
Investigative site Slovakia
Bratislava, Slovakia
Spain
Investigative site Spain
Valencia, Spain
Sweden
Investigative site Sweden
Malmo, Sweden
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CVAA489A2318
Study First Received: June 9, 2008
Last Updated: February 6, 2010
ClinicalTrials.gov Identifier: NCT00699192     History of Changes
Health Authority: Czech Republic: State Institute for Drug Control;   Finland: Finnish Medicines Agency;   France: Afssaps - French Health Products Safety Agency;   Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM);   Hungary: Országos Gyógyszerészeti Intézet;   Italy: Ministry of Health;   Slovakia: State Institute for Drug Control;   Spain: Spanish Agency of Medicines;   Sweden: Medical Products Agency;   Poland: THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS

Keywords provided by Novartis:
Blood pressure
hypertension
elderly

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010