HypertensionPhase 4NCT00698646

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

A Phase 4 study testing Valsartan + HCTZ, Valsartan and HCTZ in people with Hypertension, run by Novartis Pharmaceuticals at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Hypertension
What is being tested?: Valsartan + HCTZ, Valsartan and HCTZ
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 384 participants
Where: 20 sitesUnited States
Study dates: Apr 2008to Jun 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

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

Other trials in United States

About this study

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

Conditions: Hypertension
Being tested: Valsartan + HCTZ, Valsartan, HCTZ
Keywords: Systolic blood pressure, Diastolic blood pressure, Valsartan, Hydrochlorothiazide
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Valsartan + HCTZDrug
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.
ValsartanDrug
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.
HCTZDrug
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.

Study groups in NCT00698646
Study group	Role	What they receive
Valsartan	Active comparator	(patients initiated on valsartan) Receives: Drug: Valsartan
HCTZ	Active comparator	(patients initiated on HCTZ) Receives: Drug: HCTZ
Valsartan + HCTZ	Experimental	(patients initiated on Valsartan+HCTZ) Receives: Drug: Valsartan + HCTZ

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jun 2009

First posted17 Jun 2008 (estimated)
Study startApr 2008
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 384 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00698646
Sponsor's protocol ID: CVAH631BUS08
Status last verified: Apr 2011
First submitted: 13 Jun 2008
Last updated: 19 Apr 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22520932
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.
PubMed 22311004
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.
PubMed 21974759
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.
PubMed 21747241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00698646
Acronym / sponsor ID: CVAH631BUS08
Conditions: Hypertension
Keywords: Systolic blood pressure, Diastolic blood pressure, Valsartan, Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 384 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 17 Jun 2008 (estimated)
Results: Posted 15 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Valsartan	Active comparator	Drug: Valsartan(patients initiated on valsartan)
HCTZ	Active comparator	Drug: HCTZ(patients initiated on HCTZ)
Valsartan + HCTZ	Experimental	Drug: Valsartan + HCTZ(patients initiated on Valsartan+HCTZ)

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Valsartan + HCTZAt 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.	Drug	Valsartan + HCTZ
ValsartanAt 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.	Drug	Valsartan
HCTZAt 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.	Drug	HCTZ

Primary outcome

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

5 secondary outcomes

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 Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
Time frame: 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])
Time frame: During 16 weeks

Results and safety

Results posted to the registry on 15 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Valsartan	128	92
HCTZ	128	97
Valsartan + HCTZ	128	99

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

Time frame: Baseline and Week 4. Mean (Standard Deviation). Unit: mm Hg

Measure	Valsartan n = 128	HCTZ n = 126	Valsartan + HCTZ n = 126
Baseline	166.2 (11.07)	164.5 (11.84)	164.5 (11.86)
Week 4	157.5 (19.71)	150.9 (18.41)	147.1 (18.35)
Change in MSSBP from Baseline to Week 4	-8.6 (19.47)	-13.6 (16.81)	-17.3 (17.61)

Population analysed: Intent to treat (ITT), Last observation carried forward

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valsartan + HCTZ	3 of 128 (2.3%)	16 of 128 (12.5%)	Not reported
HCTZ	4 of 128 (3.1%)	27 of 128 (21.1%)	Not reported
Valsartan	3 of 128 (2.3%)	23 of 128 (18%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22520932Cushman 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.
Derived from this study: PubMed 22311004Weintraub 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.
Derived from this study: PubMed 21974759Izzo 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.
Derived from this study: PubMed 21747241Duprez 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.
Click here for more information on the clinical studyLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Valsartan + HCTZ, Valsartan and HCTZ in people with Hypertension, run by Novartis Pharmaceuticals at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00698646, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.