HYPERTENSIONPhase 4NCT00171782
Hypertension and Cardiovascular Risk Factors
A Phase 4 study testing VALSARTAN+HYDROCHLOROTHIAZIDE in people with HYPERTENSION, run by Novartis.
Trial summary
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors. 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+HYDROCHLOROTHIAZIDE
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Dec 2004
- Phase
- Phase 4
- 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
- - Patients who give consent
- Men and women 18 to 80 years of age
- Patients with hypertension (systolic >159 mm, diastolic >100 mm)
- Patients meeting laboratory criteria
Who cannot join
- - Pregnant women
- Women not using approved contraception methods
- Secondary hypertension
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.
- Conditions
- HYPERTENSION
- Being tested
- VALSARTAN+HYDROCHLOROTHIAZIDE
- Keywords
- HYPERTENSION, VALSARTAN, VALSARTAN AND HYDROCHLOROTHIAZIDE, RISK FACTORS
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VALSARTAN+HYDROCHLOROTHIAZIDEDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline systolic blood pressure at 8 weeks
Secondary outcomes (3)
Blood pressure less than 140/90 mmHg at 8 weeks
Reduction from baseline in diastolic blood pressure greater than or equal to 10 mmHg
Reduction from baseline in systolic blood pressure greater than or equal to 20 mmHg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171782
- Sponsor's protocol ID
- CVAH631BCO02
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2005
- Last updated
- 12 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00171782
- Acronym / sponsor ID
- CVAH631BCO02
- Conditions
- HYPERTENSION
- Keywords
- HYPERTENSION, VALSARTAN, VALSARTAN AND HYDROCHLOROTHIAZIDE, RISK FACTORS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 15 Sep 2005 (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.
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Patients who give consent
- Men and women 18 to 80 years of age
- Patients with hypertension (systolic >159 mm, diastolic >100 mm)
- Patients meeting laboratory criteria
Key exclusion criteria (4 listed)
- - Pregnant women
- Women not using approved contraception methods
- Secondary hypertension
- 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+HYDROCHLOROTHIAZIDE | Drug | – |
Primary outcome
Change from baseline systolic blood pressure at 8 weeks
3 secondary outcomes
Blood pressure less than 140/90 mmHg at 8 weeks
Reduction from baseline in diastolic blood pressure greater than or equal to 10 mmHg
Reduction from baseline in systolic blood pressure greater than or equal to 20 mmHg
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 12 Oct 2023.
Related trials for HYPERTENSION
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VALSARTAN+HYDROCHLOROTHIAZIDE in people with HYPERTENSION, run by Novartis.
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 4 inclusion and 4 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change from baseline systolic blood pressure at 8 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2023.