Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

This study has been completed.

Study NCT00446563 Information provided by Novartis

First Received on March 12, 2007. Last Updated on May 6, 2011 History of Changes

Results First Received: March 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypertension; Hypertrophy, Left Ventricular
Interventions:	Drug: Valsartan Drug: Amlodipine Drug: Hydrochlorothiazide Drug: Losartan

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 and Amlodipine	Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
Losartan and HCTZ	Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.

Participant Flow: Overall Study

	Valsartan and Amlodipine	Losartan and HCTZ
STARTED	43	47
COMPLETED	36	38
NOT COMPLETED	7	9
Adverse Event	4	3
Abnormal laboratory value(s)	0	1
Abnormal test procedure result(s)	1	0
Unsatisfactory therapeutic effect	0	3
Withdrawal by Subject	2	1
Administrative problems	0	1

Baseline Characteristics

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Reporting Groups

	Description
Valsartan and Amlodipine	Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
Losartan and HCTZ	Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.

Baseline Measures

	Valsartan and Amlodipine	Losartan and HCTZ	Total
Number of Participants [units: participants]	43	47	90
Age [units: years] Mean ± Standard Deviation	58.2 ± 12.2	57.2 ± 10.9	57.7 ± 11.5
Gender [units: participants]
Female	12	13	25
Male	31	34	65

Outcome Measures

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1. Primary:

Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline to week 52 ]

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2. Secondary:

Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ]

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3. Secondary:

Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI [ Time Frame: Baseline to week 52 ]

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4. Secondary:

Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI [ Time Frame: Baseline to week 52 ]

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5. Secondary:

Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI [ Time Frame: Baseline to week 52 ]

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6. Secondary:

Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI [ Time Frame: Baseline to week 52 ]

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7. Secondary:

Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ]

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8. Secondary:

Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI [ Time Frame: Baseline to week 52 ]

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9. Secondary:

Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ]

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10. Secondary:

Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI [ Time Frame: Baseline to week 52 ]

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11. Secondary:

Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI [ Time Frame: Baseline to week 52 ]

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12. Secondary:

Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline to week 52 ]

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13. Secondary:

Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline to week 52 ]

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14. Secondary:

Percentage of Participants Achieving Target Blood Pressure at Week 52 [ Time Frame: Week 52 ]

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15. Secondary:

Percentage of Participants Who Experienced Adverse Events (AEs) [ Time Frame: Baseline to week 52 ]

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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:	NCT00446563 History of Changes
Other Study ID Numbers:	CVAA489ADE02
Study First Received:	March 12, 2007
Results First Received:	March 31, 2011
Last Updated:	May 6, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices