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 - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 9, 2008

Last Updated Date

December 16, 2008

Start Date ^†

May 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699192 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hypertension

Intervention ^†

Drug: Amlodipine/Valsartan
Drug: Amlodipine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

670

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis Pharmaceuticals

41.61.324.1111

Location Countries ^†

Czech Republic, Finland, France, Germany, Hungary, Italy, Poland, Slovakia, Spain, Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699192

Responsible Party

External Affairs, Novartis Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

Novartis Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.