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

This study has been completed.

Study NCT00413413 Information provided by Novartis

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

Results First Received: August 6, 2009

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: Valsartan 80 mg Drug: Valsartan 160 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
A total of 1134 patients were enrolled into the single-blind period of the study, and 216 (19%) were discontinued. In total, 918 patients were randomized to the three treatment groups.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Valsartan/Amlodipine 80/5 mg	1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
Valsartan 80 mg	1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Valsartan 160 mg	1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Participant Flow for 2 periods

Period 1: Single-Blind

	Valsartan/Amlodipine 80/5 mg	Valsartan 80 mg	Valsartan 160 mg
STARTED	0 ^[1]	1134	0 ^[1]
COMPLETED	0	918	0
NOT COMPLETED	0	216	0
Adverse Event	0	9	0
Lack of Efficacy	0	5	0
Subject no longer requires study drug	0	151	0
Protocol Violation	0	16	0
Withdrawal by Subject	0	27	0
Lost to Follow-up	0	8	0

[1]	In single-blind period participants were only enrolled to Valsartan 80 mg arm.

Period 2: Double-Blind

	Valsartan/Amlodipine 80/5 mg	Valsartan 80 mg	Valsartan 160 mg
STARTED	308	307	303
COMPLETED	293	293	285
NOT COMPLETED	15	14	18
Adverse Event	6	0	5
Unsatisfactory therapeutic effect	1	2	1
Protocol deviation	1	2	1
Subject withdrew consent	4	6	9
Lost to Follow-up	3	4	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Valsartan/Amlodipine 80/5 mg	1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
Valsartan 80 mg	1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Valsartan 160 mg	1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Baseline Measures

	Valsartan/Amlodipine 80/5 mg	Valsartan 80 mg	Valsartan 160 mg	Total
Number of Participants [units: participants]	308	306	302	916
Age ^[1] [units: years] Mean ± Standard Deviation	51.6 ± 10.8	51.7 ± 8.9	51.2 ± 9.6	51.5 ± 9.8
Gender [units: participants]
Female	127	115	104	346
Male	181	191	198	570

[1]	All baseline measures were based on Full-set analysis population. Two patients were excluded from the full-set analysis population for having no post-baseline efficacy assessment. All randomized patients were included in the safety population.

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 Blood Pressure 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 Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ]

Show Outcome Measure 4

5. Secondary:

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

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:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00413413 History of Changes
Other Study ID Numbers:	CVAA489A2316
Study First Received:	December 18, 2006
Results First Received:	August 6, 2009
Last Updated:	April 26, 2011
Health Authority:	China: State Food and Drug Administration; United States: Food and Drug Administration