To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT01070043

First received: February 6, 2010

Last updated: September 13, 2011

Last verified: September 2011

History of Changes

Results First Received: September 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Hypertension High Blood Pressure
Interventions:	Drug: Amlodipine 5mg/Valsartan 80 mg Drug: Valsartan

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A 4 week run-in phase preceded the randomized, double-blind treatment phase of the study. During the run-in phase, participants took valsartan 80 mg daily before a meal. Sixty participants entered the run-in phase. Those participants who met the inclusion criteria entered the randomized, double-blind treatment phase.

Reporting Groups

	Description
Run-In Valsartan 80 mg	During run-in period, oral valsartan 80 mg once daily for 4 weeks.
Amlodipine 5 mg/Valsartan 80 mg	During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
Valsartan 160 mg	In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.

Participant Flow for 2 periods

Period 1: Run-In Phase

	Run-In Valsartan 80 mg	Amlodipine 5 mg/Valsartan 80 mg	Valsartan 160 mg
STARTED	60	0 ^[1]	0 ^[2]
COMPLETED	42	0	0
NOT COMPLETED	18	0	0
Did not Meet Inclusion Criteria	18	0	0

[1]	This combination therapy arm is used only for double-blind phase.
[2]	This monotherapy (Valsartan 160 mg) treatment arm is used only for double-blind phase.

Period 2: Double-Blind Treatment

	Amlodipine 5 mg/Valsartan 80 mg	Valsartan 160 mg
STARTED	21	21
COMPLETED	21	19
NOT COMPLETED	0	2
Adverse Event	0	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Amlodipine 5mg/Valsartan 80 mg	During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
Valsartan 160 mg	In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Total	Total of all reporting groups

Baseline Measures

	Amlodipine 5mg/Valsartan 80 mg	Valsartan 160 mg	Total
Number of Participants [units: participants]	21	21	42
Age ^[1] [units: years] Mean ± Standard Deviation	59.50 ± 13.81	55.13 ± 11.81	57.31 ± 13.81
Gender [units: participants]
Female	9	8	17
Male	12	13	25

[1]	Baseline measurements were based on safety/intent-to-treat (ITT) population.

Outcome Measures

Show All Outcome Measures

1. Primary:

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement [ Time Frame: Baseline and 8 weeks ]

Show Outcome Measure 1

2. Primary:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement [ Time Frame: Baseline and 8 weeks ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours [ Time Frame: Baseline and 8 weeks ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase [ Time Frame: Baseline and 8 weeks ]

Show Outcome Measure 4

5. Secondary:

Number of Participants With Adverse Events During Double-blind Phase [ Time Frame: 8 weeks ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 - 778- 8300

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01070043 History of Changes
Other Study ID Numbers:	CVAA489ATW01
Study First Received:	February 6, 2010
Results First Received:	September 13, 2011
Last Updated:	September 13, 2011
Health Authority:	Taiwan: Department of Health

To Top