Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

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ClinicalTrials.gov Identifier: NCT00698646

Recruitment Status : Completed

First Posted : June 17, 2008

Results First Posted : December 15, 2010

Last Update Posted : April 19, 2011

Sponsor:

Information provided by:

Novartis

Study Description

Brief Summary:

The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Valsartan + HCTZ Drug: Valsartan Drug: HCTZ	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	384 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A 16 Week Multi-center, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Valsartan/Hydrochlorothiazide (HCTZ) Combination Therapy Compared to Patients Initiated With Valsartan Monotherapy or Hydrochlorothiazide (HCTZ) Monotherapy in Very Elderly Patients With Essential Hypertension
Study Start Date :	April 2008
Actual Primary Completion Date :	June 2009
Actual Study Completion Date :	June 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension

Drug Information available for: Hydrochlorothiazide Valsartan

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Valsartan (patients initiated on valsartan)	Drug: Valsartan At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
Active Comparator: HCTZ (patients initiated on HCTZ)	Drug: HCTZ At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
Experimental: Valsartan + HCTZ (patients initiated on Valsartan+HCTZ)	Drug: Valsartan + HCTZ At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.

Outcome Measures

Primary Outcome Measures :

Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 4 ]

Secondary Outcome Measures :

Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Weeks 4, 8, 12 and 16 ]
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Weeks 8, 12, and 16 ]
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg [ Time Frame: Weeks 4, 8, 12 and 16 ]
Cumulative refers to achieving of blood pressure control before or at the corresponding visit.
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg) [ Time Frame: Weeks 4, 8, 12 and 16 ]
Cumulative refers to achieving blood pressure goal before or at the corresponding visit.
Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg]) [ Time Frame: During 16 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	70 Years and older (Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 70 years or older.
Patients with hypertension prior to being randomized into study.
Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
Have the ability to communicate and comply with all study requirements.
Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion Criteria:

Use of other investigational drugs within 30 days of enrollment.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
Other protocol-defined exclusion criteria may apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698646

Locations

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United States, Alabama
Investigative site
Birmingham, Alabama, United States
United States, Arizona
Investigative site
Phoenix, Arizona, United States
United States, California
Investigative Site
Escondido, California, United States
Investigative site
Fresno, California, United States
Investigative site
Huntington Park, California, United States
Investigative Sites
Pismo Beach, California, United States
United States, Florida
Investigative site
Miami, Florida, United States
Investigative site
Ormond Beach, Florida, United States
United States, Georgia
Investigative site
Conyers, Georgia, United States
United States, Kentucky
Investigative Site
Lexington, Kentucky, United States
United States, Maine
Investigative site
Portland, Maine, United States
United States, Nevada
Investigative site
Las Vegas, Nevada, United States
United States, New York
Investigative site
Buffalo, New York, United States
United States, North Carolina
Investigative site
Shelby, North Carolina, United States
United States, Ohio
Investigative site
Carlisle, Ohio, United States
United States, Oklahoma
Investigative site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Investigative site
Erie, Pennsylvania, United States
United States, South Carolina
Investigative Site
Greer, South Carolina, United States
Investigative Site
Taylors, South Carolina, United States
United States, Utah
Investigative site
St George, Utah, United States

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

Additional Information:

Click here for more information on the clinical study This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cushman WC, Duprez DA, Weintraub HS, Purkayastha D, Zappe D, Samuel R, Izzo JL Jr. Home and clinic blood pressure responses in elderly individuals with systolic hypertension. J Am Soc Hypertens. 2012 May-Jun;6(3):210-8. doi: 10.1016/j.jash.2012.03.001.

Weintraub HS, Duprez DA, Cushman WC, Zappe DH, Purkayastha D, Samuel R, Izzo JL Jr. Antihypertensive response to thiazide diuretic or angiotensin receptor blocker in elderly hypertensives is not influenced by pretreatment plasma renin activity. Cardiovasc Drugs Ther. 2012 Apr;26(2):145-55. doi: 10.1007/s10557-011-6365-x.

Izzo JL Jr, Weintraub HS, Duprez DA, Purkayastha D, Zappe D, Samuel R, Cushman WC. Treating systolic hypertension in the very elderly with valsartan-hydrochlorothiazide vs. either monotherapy: ValVET primary results. J Clin Hypertens (Greenwich). 2011 Oct;13(10):722-30. doi: 10.1111/j.1751-7176.2011.00498.x. Epub 2011 Jul 14.

Duprez DA, Weintraub HS, Cushman WC, Purkayastha D, Zappe D, Samuel R, Izzo JL Jr. Effect of valsartan, hydrochlorothiazide, and their combination on 24-h ambulatory blood pressure response in elderly patients with systolic hypertension: a ValVET substudy. Blood Press Monit. 2011 Aug;16(4):186-96. doi: 10.1097/MBP.0b013e32834944e9.

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Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00698646
Other Study ID Numbers:	CVAH631BUS08
First Posted:	June 17, 2008 Key Record Dates
Results First Posted:	December 15, 2010
Last Update Posted:	April 19, 2011
Last Verified:	April 2011

Keywords provided by Novartis:


Systolic blood pressure Diastolic blood pressure Valsartan Hydrochlorothiazide

Additional relevant MeSH terms:

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Hypertension Vascular Diseases Cardiovascular Diseases Valsartan Hydrochlorothiazide Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers	Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators

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