Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension

This study has been completed.

Study NCT00171054 Information provided by Novartis

First Received on September 10, 2005. Last Updated on June 2, 2011 History of Changes

Results First Received: December 21, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Valsartan 320 mg Drug: Amlodipine 10 mg Drug: Hydrochlorothiazide

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 320 mg	Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine 10 mg	Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.

Participant Flow: Overall Study

	Valsartan 320 mg	Amlodipine 10 mg
STARTED	63	62
COMPLETED	53	50
NOT COMPLETED	10	12
Protocol Violation	1	2
Patient withdrew consent	1	0
Lost to Follow-up	0	1
Adverse Event	8	8
Condition no longer required study drug	0	1

Baseline Characteristics

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Reporting Groups

	Description
Valsartan 320 mg	Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
Amlodipine 10 mg	Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.

Baseline Measures

	Valsartan 320 mg	Amlodipine 10 mg	Total
Number of Participants [units: participants]	63	62	125
Age [units: years] Mean ± Standard Deviation	62.3 ± 5.76	60.4 ± 5.08	61.4 ± 5.50
Gender [units: participants]
Female	63	62	125
Male	0	0	0

Outcome Measures

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1. Primary:

Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV) [ Time Frame: Baseline and Week 38 ]

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2. Secondary:

Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12 [ Time Frame: Baseline and Week 12 ]

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3. Secondary:

Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38) [ Time Frame: Week 38 ]

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4. Secondary:

Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12 [ Time Frame: Baseline and Week 12 ]

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5. Secondary:

Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38) [ Time Frame: Baseline and Week 38 ]

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6. Secondary:

Changes in Mean Left Carotid Distensibility at Week 12 [ Time Frame: Baseline and Week 12 ]

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7. Secondary:

Changes in Mean Left Carotid Distensibility at Week 38 [ Time Frame: Baseline and Week 38 ]

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8. Secondary:

Changes in Mean Right Carotid Distensibility at Week 12 [ Time Frame: Baseline and Week 12 ]

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9. Secondary:

Changes in Mean Right Carotid Distensibility at Week 38 [ Time Frame: Baseline and Week 38 ]

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10. Secondary:

Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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11. Secondary:

Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38 [ Time Frame: Baseline and Week 38 ]

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12. Secondary:

Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38 [ Time Frame: Baseline and Week 38 ]

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13. Secondary:

Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38 [ Time Frame: Baseline, Week 12 and Week 38 ]

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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

ClinicalTrials.gov Identifier:	NCT00171054 History of Changes
Other Study ID Numbers:	CVAL489A2418
Study First Received:	September 10, 2005
Results First Received:	December 21, 2010
Last Updated:	June 2, 2011
Health Authority:	Switzerland: Swissmedic