Trial · NCT00446563

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

NCT00446563, Phase 3, Completed, Novartis; results first posted 2011-04-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy. Trials, record NCT00446563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00446563

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy
NCT number: NCT00446563
Status: Completed
Phases: Phase 3
Enrollment: 90 participants, actual
Lead sponsor: Novartis
Conditions: Hypertension; Hypertrophy, Left Ventricular
Interventions: Valsartan, Amlodipine, Hydrochlorothiazide, Losartan
First posted: 2007-03-13
Last updated: 2011-05-11
Results first posted: 2011-04-27

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)	Baseline to week 52
Secondary	Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI	Baseline to week 52
Secondary	Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI	Baseline to week 52
Secondary	Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI	Baseline to week 52
Secondary	Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI	Baseline to week 52	Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
Secondary	Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI	Baseline to week 52
Secondary	Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI	Baseline to week 52
Secondary	Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI	Baseline to week 52
Secondary	Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI	Baseline to week 52
Secondary	Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI	Baseline to week 52

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	g/m˄2	MEAN
SECONDARY	Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	g/m˄2	MEAN
SECONDARY	Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	mm	MEAN
SECONDARY	Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	mm	MEAN
SECONDARY	Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	Percentage	MEAN
SECONDARY	Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	ml	MEAN
SECONDARY	Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	ml	MEAN
SECONDARY	Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	ml	MEAN
SECONDARY	Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	ml	MEAN
SECONDARY	Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI	Baseline to week 52	The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.	cm˄2	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)	Valsartan and Amlodipine	-7.1	Standard Deviation 16.50	g/m˄2
Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)	Losartan and HCTZ	-9.1	Standard Deviation 18.89	g/m˄2
Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI	Valsartan and Amlodipine	-3.5	Standard Deviation 7.4	g/m˄2
Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI	Losartan and HCTZ	-4.4	Standard Deviation 9.3	g/m˄2
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI	Valsartan and Amlodipine	-1.1	Standard Deviation 1.5	mm
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI	Losartan and HCTZ	-0.6	Standard Deviation 1.3	mm
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI	Valsartan and Amlodipine	-0.4	Standard Deviation 1.1	mm
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI	Losartan and HCTZ	-0.3	Standard Deviation 1.2	mm
Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI	Valsartan and Amlodipine	-0.8	Standard Deviation 6.7	Percentage
Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI	Losartan and HCTZ	-0.4	Standard Deviation 5.9	Percentage

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Valsartan and Amlodipine	43
Overall Study	STARTED	Losartan and HCTZ	47
Overall Study	COMPLETED	Valsartan and Amlodipine	36
Overall Study	COMPLETED	Losartan and HCTZ	38
Overall Study	NOT COMPLETED	Valsartan and Amlodipine	7
Overall Study	NOT COMPLETED	Losartan and HCTZ	9

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	DIARRHOEA	Gastrointestinal disorders	Valsartan and Amlodipine	1	43
other	DIARRHOEA	Gastrointestinal disorders	Losartan and HCTZ	4	47
other	NAUSEA	Gastrointestinal disorders	Valsartan and Amlodipine	1	43
other	NAUSEA	Gastrointestinal disorders	Losartan and HCTZ	3	47
other	OEDEMA PERIPHERAL	General disorders	Valsartan and Amlodipine	4	43
other	OEDEMA PERIPHERAL	General disorders	Losartan and HCTZ	0	47
other	BRONCHITIS	Infections and infestations	Valsartan and Amlodipine	3	43
other	BRONCHITIS	Infections and infestations	Losartan and HCTZ	0	47
other	NASOPHARYNGITIS	Infections and infestations	Valsartan and Amlodipine	3	43
other	NASOPHARYNGITIS	Infections and infestations	Losartan and HCTZ	7	47

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Valsartan and Amlodipine
Total, all-cause mortality	Losartan and HCTZ
Total, other adverse events	Valsartan and Amlodipine	15	43
Total, other adverse events	Losartan and HCTZ	16	47
Total, serious adverse events	Valsartan and Amlodipine	2	43
Total, serious adverse events	Losartan and HCTZ	6	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27536421	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Valsartan and Amlodipine vs Losartan and HCTZ: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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