HypertensionPhase 3NCT00394823
VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients
A Phase 3 study of Hypertension, run by Novartis at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 206 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2005to Jun 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients >= 18 years
- Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
- Patients with mild essential hypertension: Systolic blood pressure ≥ 140 mmHg and < 170 and/or diastolic blood pressure ≥ 90 mmHg and < 105 mmHg"
Who cannot join
- Moderate and severe hypertension
- Pregnant or nursing women
- A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Open-label, Multicentric Parallel Group Study to Assess the Impact of Supportive Measures on the Drug Adherence of Patients With Essential Hypertension Treated With Valsartan or Valsartan Plus HCTZ for 34 Weeks With or Without Respective Measures
The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension
- Conditions
- Hypertension
- Being tested
- Set of supportive tools/measures vs. standard care
- Keywords
- Hypertension, valsartan, compliance
- Medical subject headings
- Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Set of supportive tools/measures vs. standard careBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)
Secondary outcomes (6)
Compliance and persistence between randomized groups over time.
To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy
To assess the relation between drug exposure and BP reduction.
To assess the relation between drug exposure and the likelihood to switch to valsartan 160 mg plus HCTZ 12.5 mg
To assess the safety and tolerability of valsartan 160 mg and valsartan 160 mg plus
HCTZ 12.5 mg.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startNov 2005
- Primary completionJun 2007
- Study completionJun 2007
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Basel, Study chair, +41 61 324 1111
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394823
- Sponsor's protocol ID
- CVAL489ADE24
- Status last verified
- May 2017
- First submitted
- 31 Oct 2006
- Last updated
- 18 May 2017
- Results posted
- No
Publications
Dusing R, Handrock R, Klebs S, Tousset E, Vrijens B. Impact of supportive measures on drug adherence in patients with essential hypertension treated with valsartan: the randomized, open-label, parallel group study VALIDATE. J Hypertens. 2009 Apr;27(4):894-901. doi: 10.1097/HJH.0b013e328323f9be.
PubMed 19300114
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicentric Parallel Group Study to Assess the Impact of Supportive Measures on the Drug Adherence of Patients With Essential Hypertension Treated With Valsartan or Valsartan Plus HCTZ for 34 Weeks With or Without Respective Measures
- ClinicalTrials.gov ID
- NCT00394823
- Acronym / sponsor ID
- CVAL489ADE24
- Conditions
- Hypertension
- Keywords
- Hypertension, valsartan, compliance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 1 Nov 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 impact of supportive measures on the drug adherence of patients with essential hypertension
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients >= 18 years
- Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
- Patients with mild essential hypertension: Systolic blood pressure ≥ 140 mmHg and < 170 and/or diastolic blood pressure ≥ 90 mmHg and < 105 mmHg"
Key exclusion criteria (4 listed)
- Moderate and severe hypertension
- Pregnant or nursing women
- A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
- Other protocol-defined inclusion/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 |
|---|---|---|
| Set of supportive tools/measures vs. standard care | Behavioural | – |
Primary outcome
Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)
6 secondary outcomes
Compliance and persistence between randomized groups over time.
To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy
To assess the relation between drug exposure and BP reduction.
To assess the relation between drug exposure and the likelihood to switch to valsartan 160 mg plus HCTZ 12.5 mg
To assess the safety and tolerability of valsartan 160 mg and valsartan 160 mg plus
HCTZ 12.5 mg.
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 18 May 2017.
- Derived from this study: PubMed 19300114Dusing R, Handrock R, Klebs S, Tousset E, Vrijens B. Impact of supportive measures on drug adherence in patients with essential hypertension treated with valsartan: the randomized, open-label, parallel group study VALIDATE. J Hypertens. 2009 Apr;27(4):894-901. doi: 10.1097/HJH.0b013e328323f9be.
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 Basel study chair
+41 61 324 1111
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hypertension, run by Novartis at 2 sites in 2 countries.
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 3 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 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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?
Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed). 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 NCT00394823, 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 18 May 2017.