Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients

This study has been completed.

Study NCT00396656 Information provided by Novartis

First Received on November 6, 2006. Last Updated on May 5, 2011 History of Changes

Results First Received: January 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Atenolol Drug: Hydrochlorothiazide (HCTZ)) Drug: Valsartan

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)	After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning. After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.
Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan	After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning. After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning

Description

Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)

After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.

After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.

Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan

After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.

After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning

Participant Flow for 2 periods

Period 1: First Treatment Period

	Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)	Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan
STARTED	15	15
COMPLETED	15	13
NOT COMPLETED	0	2
Withdrawal by Subject	0	2

Period 2: Second Treatment Period

	Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)	Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan
STARTED	15	13
COMPLETED	15	12
NOT COMPLETED	0	1
Adverse Event	0	1

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Includes patients that received valsartan followed by atenolol + hydrochlorothiazide and patients that received atenolol + hydrochlorothiazide followed by valsartan.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	30
Age [units: years] Mean ± Standard Deviation	52.3 ± 7.2
Gender [units: participants]
Female	11
Male	19

Outcome Measures

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1. Primary:

Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]

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2. Secondary:

Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]

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3. Secondary:

Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]

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4. Secondary:

Mean Post-treatment Microcirculation at NaCl Injected Sites [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]

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5. Secondary:

Arterial Pressure Waveform Augmentation Index at the End of Treatment [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]

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6. Secondary:

Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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 (ie, 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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Anna Mitchell, MD, University Hospital Essen, Essen, Germany et al.
ClinicalTrials.gov Identifier:	NCT00396656 History of Changes
Other Study ID Numbers:	CVAH631BDE06
Study First Received:	November 6, 2006
Results First Received:	January 7, 2011
Last Updated:	May 5, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices