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.

Study NCT00699192 Information provided by Novartis

First Received on June 9, 2008. Last Updated on May 4, 2011 History of Changes

Results First Received: January 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Amlodipine 5 mg Drug: Valsartan 80 mg Drug: Valsartan 40 mg Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
965 patients were enrolled in the study. Of these, 819 met the criteria for entry into the double-blind phase of the study where efficacy and safety were evaluated.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Amlodipine/Valsartan 5/80 mg	1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
Amlodipine/Valsartan 5/40 mg	1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
Amlodipine 5 mg	1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily

Participant Flow: Overall Study

	Amlodipine/Valsartan 5/80 mg	Amlodipine/Valsartan 5/40 mg	Amlodipine 5 mg
STARTED	275	272	272
COMPLETED	259	260	261
NOT COMPLETED	16	12	11
Missing	1	1	1
Adverse Event	9	4	3
Abnormal test procedure result(s)	0	0	1
Lack of Efficacy	0	0	1
Withdrawal by Subject	3	2	4
Administrative problems	1	3	1
Protocol Violation	2	2	0

Baseline Characteristics

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Reporting Groups

	Description
Amlodipine/Valsartan 5/80 mg	1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
Amlodipine/Valsartan 5/40 mg	1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
Amlodipine 5 mg	1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily

Baseline Measures

	Amlodipine/Valsartan 5/80 mg	Amlodipine/Valsartan 5/40 mg	Amlodipine 5 mg	Total
Number of Participants [units: participants]	275	272	272	819
Age [units: years] Mean ± Standard Deviation	71.8 ± 5.01	71.6 ± 5.38	71.4 ± 5.44	71.6 ± 5.27
Gender [units: participants]
Female	152	138	142	432
Male	123	134	130	387

Outcome Measures

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1. Primary:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]

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2. Secondary:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]

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3. Secondary:

Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8 [ Time Frame: Baseline to end of study (Week 8) ]

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4. Secondary:

Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ]

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5. Secondary:

Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00699192 History of Changes
Other Study ID Numbers:	CVAA489A2318
Study First Received:	June 9, 2008
Results First Received:	January 11, 2011
Last Updated:	May 4, 2011
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: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products