Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg - Study Results

Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg (EXPLOR)

This study has been completed.

Study NCT00687973 Information provided by Novartis

First Received on March 20, 2008. Last Updated on March 8, 2011 History of Changes

Results First Received: December 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Valsartan/amlodipine 80/5 mg tablets Drug: Amlodipine 5 mg capsules Drug: Amlodipine 10 mg capsules Drug: Atenolol 50 mg tablets Drug: Atenolol 100 mg tablets

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
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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
Valsartan/Amlodipine 160/10 mg	Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Atenolol/Amlodipine 100/10 mg	Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.

Participant Flow: Overall Study

	Valsartan/Amlodipine 160/10 mg	Atenolol/Amlodipine 100/10 mg
STARTED	193	200
COMPLETED	169	162
NOT COMPLETED	24	38
Adverse Event	18	28
Lack of Efficacy	2	3
Protocol Violation	1	2
Administrative Reasons	0	2
Withdrawal by Subject	3	3

Baseline Characteristics

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Reporting Groups

	Description
Valsartan/Amlodipine 160/10 mg	Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Atenolol/Amlodipine 100/10 mg	Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.

Baseline Measures

	Valsartan/Amlodipine 160/10 mg	Atenolol/Amlodipine 100/10 mg	Total
Number of Participants [units: participants]	193	200	393
Age [units: years] Mean ± Standard Deviation	57.5 ± 9.94	56.2 ± 11.09	56.9 ± 10.55
Gender [units: participants]
Female	82	101	183
Male	111	99	210
Region of Enrollment [units: participants]
France	193	200	393

Outcome Measures

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1. Primary:

Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ]

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2. Secondary:

Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement) [ Time Frame: Baseline and Week 8 ]

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3. Secondary:

Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ]

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4. Secondary:

Change From Baseline of Augmentation Index (Aix) at Week 8 [ Time Frame: Baseline and Week 8 ]

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5. Secondary:

Change From Baseline of Aix at Week 24 [ Time Frame: Baseline and Week 24 ]

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6. Secondary:

Change From Baseline of Aix Corrected to Heart Rate at Week 24 [ Time Frame: Baseline and Week 24 ]

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7. Secondary:

Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ]

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8. Secondary:

Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center) [ Time Frame: Baseline and Week 24 ]

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9. Secondary:

Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center) [ Time Frame: Baseline and Week 24 ]

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10. Secondary:

Change From Baseline of SBP/DBP at Week 24 (Office BP) [ Time Frame: Baseline and Week 24 ]

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11. Secondary:

Change From Baseline of Pulse Pressure at Week 24 (Office BP) [ Time Frame: Baseline and Week 24 ]

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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:	NCT00687973 History of Changes
Other Study ID Numbers:	CVAA489AFR02
Study First Received:	March 20, 2008
Results First Received:	December 22, 2010
Last Updated:	March 8, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Ministry of Health