HypertensionPhase 3NCT00273299
Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension
A Phase 3 study testing valsartan plus hydrochlorothiazide in people with Hypertension, run by Novartis at 1 site in United States.
Trial summary
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan plus hydrochlorothiazide
- How many people
- 607 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jul 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosed severe hypertension
Who cannot join
- Inability to discontinue all prior antihypertensive medications
- Heart failure of any kind
- History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
- Diabetes with poor glucose control
- Allergy to certain medications used to treat high blood pressure
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A 6-Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.
- Conditions
- Hypertension
- Being tested
- valsartan plus hydrochlorothiazide
- Keywords
- hypertension, high blood pressure, valsartan/hydrochlorozide, severe hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartan plus hydrochlorothiazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure less than 140/90 mmHg after 4 weeks
Secondary outcomes (5)
Blood pressure less than 140/90 mmHg after 6 weeks
Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks
Systolic blood pressure less than 140 mmHg after 4 and 6 weeks
Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks
Adverse events and serious adverse events at each study visit for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startNov 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273299
- Sponsor's protocol ID
- CVAH631D2301
- Status last verified
- Nov 2011
- First submitted
- 4 Jan 2006
- Last updated
- 8 Nov 2011
- Results posted
- No
Publications
Calhoun DA, Glazer RD, Pettyjohn FS, Coenen PD, Zhao Y, Grosso A. Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension. Curr Med Res Opin. 2008 Aug;24(8):2303-11. doi: 10.1185/03007990802271946. Epub 2008 Jun 28.
PubMed 18593517
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension
- ClinicalTrials.gov ID
- NCT00273299
- Acronym / sponsor ID
- CVAH631D2301
- Conditions
- Hypertension
- Keywords
- hypertension, high blood pressure, valsartan/hydrochlorozide, severe hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed severe hypertension
Key exclusion criteria (6 listed)
- Inability to discontinue all prior antihypertensive medications
- Heart failure of any kind
- History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
- Diabetes with poor glucose control
- Allergy to certain medications used to treat high blood pressure
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 plus hydrochlorothiazide | Drug | – |
Primary outcome
Blood pressure less than 140/90 mmHg after 4 weeks
5 secondary outcomes
Blood pressure less than 140/90 mmHg after 6 weeks
Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks
Systolic blood pressure less than 140 mmHg after 4 and 6 weeks
Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks
Adverse events and serious adverse events at each study visit for 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- Derived from this study: PubMed 18593517Calhoun DA, Glazer RD, Pettyjohn FS, Coenen PD, Zhao Y, Grosso A. Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension. Curr Med Res Opin. 2008 Aug;24(8):2303-11. doi: 10.1185/03007990802271946. Epub 2008 Jun 28.
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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.
Novartis Pharmaceuticals study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valsartan plus hydrochlorothiazide in people with Hypertension, run by Novartis at 1 site 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 1 inclusion and 6 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 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood pressure less than 140/90 mmHg after 4 weeks. 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 NCT00273299, which also lists 1 linked publication.
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 8 Nov 2011; AzTrials last refreshed its copy on 8 Nov 2026.