Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension (EXALT)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00931710

First received: July 1, 2009

Last updated: March 1, 2011

Last verified: March 2011

History of Changes

Results First Received: January 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Stage 2 Systolic Hypertension
Interventions:	Drug: valsartan, amlodipine, HCTZ Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ

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/HCTZ

Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.

Losartan/HCTZ

Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.

Participant Flow: Overall Study

	Valsartan/Amlodipine/HCTZ	Losartan/HCTZ
STARTED	241	247
COMPLETED	207	209
NOT COMPLETED	34	38
Adverse Event	16	10
Abnormal test procedure results	2	0
Unsatisfactory therapeutic effects	5	12
Patient withdrew consent	4	9
Lost to Follow-up	6	5
Protocol deviation	1	2

Baseline Characteristics

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Reporting Groups

	Description
Valsartan/Amlodipine/HCTZ	Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
Losartan/HCTZ	Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Total	Total of all reporting groups

Baseline Measures

	Valsartan/Amlodipine/HCTZ	Losartan/HCTZ	Total
Number of Participants [units: participants]	241	247	488
Age [units: years] Mean ± Standard Deviation	55.0 ± 9.83	57.1 ± 9.69	56.1 ± 9.81
Gender [units: participants]
Female	102	111	213
Male	139	136	275

Outcome Measures

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1. Primary:

Change in Mean Sitting Systolic Blood Pressure After 6 Weeks [ Time Frame: Baseline to Week 6 ]

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2. Secondary:

Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks [ Time Frame: Baseline to Week 6 ]

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3. Secondary:

Cumulative Percentage of Patients Achieving Blood Pressure Control [ Time Frame: 3 and 6 weeks ]

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4. Secondary:

Cumulative Percentage of Treatment Responders [ Time Frame: 3 and 6 weeks ]

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5. Secondary:

Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks [ Time Frame: Baseline to week 12 ]

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6. Secondary:

Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit [ Time Frame: 3, 6, 9 and 12 weeks ]

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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:	NCT00931710 History of Changes
Other Study ID Numbers:	CVEA489AUS01
Study First Received:	July 1, 2009
Results First Received:	January 13, 2011
Last Updated:	March 1, 2011
Health Authority:	United States: Food and Drug Administration

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