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

NCT00698646 | Completed Phase 4 Results

• 1 other identifier: CVAH631BUS08
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 20

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

Conditions

Hypertension

Keywords

Systolic blood pressure; Diastolic blood pressure; Valsartan; Hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

  Baseline and Week 4

Secondary Outcomes (5)

• Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)

  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)

  Baseline and Weeks 8, 12, and 16

• Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg

  Weeks 4, 8, 12 and 16

• Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)

  Weeks 4, 8, 12 and 16

• 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])

  During 16 weeks

Study Arms (3)

Valsartan

ACTIVE COMPARATOR

(patients initiated on valsartan)

Drug: Valsartan

HCTZ

ACTIVE COMPARATOR

(patients initiated on HCTZ)

Drug: HCTZ

Valsartan + HCTZ

EXPERIMENTAL

(patients initiated on Valsartan+HCTZ)

Drug: Valsartan + HCTZ

Interventions

Valsartan + HCTZ DRUG

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.

Valsartan + HCTZ

Valsartan DRUG

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.

Valsartan

HCTZ DRUG

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.

HCTZ

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Investigative site

Birmingham, Alabama, United States

Location

Investigative site

Phoenix, Arizona, United States

Location

Investigative Site

Escondido, California, United States

Location

Investigative site

Fresno, California, United States

Location

Investigative site

Huntington Park, California, United States

Location

Investigative Sites

Pismo Beach, California, United States

Location

Investigative site

Miami, Florida, United States

Location

Investigative site

Ormond Beach, Florida, United States

Location

Investigative site

Conyers, Georgia, United States

Location

Investigative Site

Lexington, Kentucky, United States

Location

Investigative site

Portland, Maine, United States

Location

Investigative site

Las Vegas, Nevada, United States

Location

Investigative site

Buffalo, New York, United States

Location

Investigative site

Shelby, North Carolina, United States

Location

Investigative site

Carlisle, Ohio, United States

Location

Investigative site

Oklahoma City, Oklahoma, United States

Location

Investigative site

Erie, Pennsylvania, United States

Location

Investigative Site

Greer, South Carolina, United States

Location

Investigative Site

Taylors, South Carolina, United States

Location

Investigative site

St. George, Utah, United States

Location

Related Publications (4)

• 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.

  PMID: 22520932 DERIVED

• 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.

  PMID: 22311004 DERIVED

• 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.

  PMID: 21974759 DERIVED

• 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.

  PMID: 21747241 DERIVED

Related Links

• Click here for more information on the clinical study

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 19, 2011
• Results First Posted: December 15, 2010

Record last verified: 2011-04

Locations

US (20)