Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

This study has been completed.

Study NCT00413049 Information provided by Novartis

First Received on December 18, 2006. Last Updated on April 26, 2011 History of Changes

Results First Received: January 11, 2011

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

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
Two patients in the valsartan/amlodipine group were excluded from the intent-to-treat population used for the efficacy analyses for having no post-baseline efficacy assessment.

Reporting Groups

	Description
Valsartan/Amlodipine 80/5 mg	1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Amlodipine 5 mg	1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

Participant Flow: Overall Study

	Valsartan/Amlodipine 80/5 mg	Amlodipine 5 mg
STARTED	349	349
COMPLETED	325	331
NOT COMPLETED	24	18
Adverse Event	10	8
Withdrawal by Subject	7	5
Lost to Follow-up	2	3
Protocol Violation	3	1
Subject no longer requires study drug	0	1
Abnormal laboratory value(s)	1	0
Lack of Efficacy	1	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Valsartan/Amlodipine 80/5 mg	1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Amlodipine 5 mg	1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

Baseline Measures

	Valsartan/Amlodipine 80/5 mg	Amlodipine 5 mg	Total
Number of Participants [units: participants]	347	349	696
Age [units: years] Mean ± Standard Deviation	53.4 ± 9.7	54.2 ± 9.1	53.8 ± 9.4
Gender [units: participants]
Female	134	109	243
Male	213	240	453

Outcome Measures

Show All Outcome Measures

1. Primary:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]

Show Outcome Measure 1

2. Secondary:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]

Show Outcome Measure 2

3. Secondary:

Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]

Show Outcome Measure 3

4. Secondary:

Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]

Show Outcome Measure 4

5. Secondary:

Percentage of Patients Achieving Overall Control at the End of the Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]

Show Outcome Measure 5

6. Secondary:

Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]

Show Outcome Measure 6

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 Medical Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00413049 History of Changes
Other Study ID Numbers:	CVAA489A2315
Study First Received:	December 18, 2006
Results First Received:	January 11, 2011
Last Updated:	April 26, 2011
Health Authority:	China: State Food and Drug Administration; United States: Food and Drug Administration