Effect of the Fixed Dose Combination Amlodipine/Valsartan... | NCT00687973

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Valsartan/amlodipine 160/10 mg	Experimental	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.	Drug: Valsartan/amlodipine 80/5 mg tablets
Atenolol/amlodipine 100/10 mg	Active Comparator	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.	Drug: Amlodipine 5 mg capsules Drug: Amlodipine 10 mg capsules Drug: Atenolol 50 mg tablets Drug: Atenolol 100 mg tablets

Name	Type	Description	Arm Group Labels	Other Names
Valsartan/amlodipine 80/5 mg tablets	Drug		Valsartan/amlodipine 160/10 mg
Amlodipine 5 mg capsules

Outcomes Module

Measure	Description	Time Frame
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)		Baseline and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)		Baseline and Week 8
Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)		Baseline and Week 24

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
2 & 4 rue Lionel Terray BP 308		Rueil-Malmaison		92506	France

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000193 BG001200 BG002393

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00057.5± 9.94 BG00156.2± 11.09 BG00256.9± 10.55

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00082 BG001101 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

France

Title	Measurements
	BG000193 BG001200 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)

Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000176 OG001178

Title

Denominators

Categories

Title	Measurements
	OG000-13.65± 1.15 OG001-9.7± 1.09

Secondary

Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)

Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 8

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)

Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline of Augmentation Index (Aix) at Week 8

To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.

Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

Ratio

Baseline and Week 8

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change From Baseline of Aix at Week 24

Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

Ratio

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline of Aix Corrected to Heart Rate at Week 24

The heart rate correction was computed by a multivariate model analysis

Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

Ratio

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)

Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

m/s

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)

Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.

ITT population

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)

ITT Population

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline of SBP/DBP at Week 24 (Office BP)

ITT Population

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline of Pulse Pressure at Week 24 (Office BP)

ITT Population

Posted

Least Squares Mean

Standard Deviation

mmHg

Baseline and Week 24

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Amlodipine 5 mg	Run-in: Amlodipine 5 mg	3	393	10	393
EG001	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.	4	193	30	193
EG002	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.	4	200	31	200

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Colitis ulcerative	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0011 affected193 at risk EG0020 affected200 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected393 at risk EG0010 affected193 at risk EG0020 affected200 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0010 affected193 at risk EG0021 affected200 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0011 affected193 at risk EG0020 affected200 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0010 affected193 at risk EG0021 affected200 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0010 affected193 at risk EG0021 affected200 at risk
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0010 affected193 at risk EG0021 affected200 at risk
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected393 at risk EG0010 affected193 at risk EG0020 affected200 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected393 at risk EG0010 affected193 at risk EG0020 affected200 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0011 affected193 at risk EG0020 affected200 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected393 at risk EG0010 affected193 at risk EG0020 affected200 at risk
Cyst removal	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0011 affected193 at risk EG0020 affected200 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0010 affected193 at risk EG0021 affected200 at risk
Joint arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected393 at risk EG0011 affected193 at risk EG0020 affected200 at risk

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D014633	Valine
D000597	Amino Acids, Branched-Chain
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000601	Amino Acids, Essential
D004095	Dihydropyridines
D011725	Pyridines
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D020005	Propanols
D000588	Amines