HypertensionPhase 3NCT00548067
Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension
A Phase 3 study testing Valsartan/hydrochlorothiazide (HCTZ), Valsartan/amlodipine and Amlodipine/hydrochlorothiazide(HCTZ) in people with Hypertension, run by Novartis at 5 sites in India.
Trial summary
The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsartan/hydrochlorothiazide (HCTZ), Valsartan/amlodipine and Amlodipine/hydrochlorothiazide(HCTZ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 5 sitesIndia
- Study dates
- Sep 2007to Mar 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed as hypertensive
- Untreated confirmed hypertensive patients (consistent SBP >140 mm Hg or DBP >90 mm Hg)
- Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on one drug therapy.
- Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on two drug therapy.
Who cannot join
- Inability to switch from all prior antihypertensive medications safely as required by the protocol.
- Need for drugs other than study drugs at the time of baseline.
- Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.
- Patients on four or more antihypertensive drugs at screening.
- Pregnant or nursing (lactating) women.
- Patients with diabetes mellitus
- Patients with heart diseases and any other disease
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Novartis Investigative Site
Ahmedabad
Novartis investigative site
Bangalore
Novartis Investigative site
Hyderabad
Novartis Investigative site
Mangalore
Novartis investigative site
Mehasana
About this study
Official title: A Multi-center, Multiple Dose, Open-label, Four-cohort, Parallel Study to Assess the Pharmacokinetic Drug Interaction Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension.
The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.
- Conditions
- Hypertension
- Being tested
- Valsartan/hydrochlorothiazide (HCTZ), Valsartan/amlodipine, Amlodipine/hydrochlorothiazide(HCTZ), Valsartan/amlodipine/hydrochlorothiazide(HCTZ)
- Keywords
- High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan/hydrochlorothiazide (HCTZ)Drug
Valsartan/amlodipineDrug
Amlodipine/hydrochlorothiazide(HCTZ)Drug
Valsartan/amlodipine/hydrochlorothiazide(HCTZ)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Valsartan/hydrochlorothiazide (HCTZ) |
| 2 | Active comparator | Not described Receives: Drug: Valsartan/amlodipine |
| 3 | Active comparator | Not described Receives: Drug: Amlodipine/hydrochlorothiazide(HCTZ) |
| 4 | Experimental | Not described Receives: Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential drug interaction and effect on blood level of drugs when co-administered for 17 days
Secondary outcomes (1)
Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startSep 2007
- Study completionMar 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Novartis investigative site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548067
- Sponsor's protocol ID
- CVEA489A2104
- Status last verified
- Sep 2010
- First submitted
- 22 Oct 2007
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Multiple Dose, Open-label, Four-cohort, Parallel Study to Assess the Pharmacokinetic Drug Interaction Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension.
- ClinicalTrials.gov ID
- NCT00548067
- Acronym / sponsor ID
- CVEA489A2104
- Conditions
- Hypertension
- Keywords
- High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Mar 2008 (actual)
- First posted
- 23 Oct 2007 (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 determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Valsartan/hydrochlorothiazide (HCTZ) |
| 2 | Active comparator | Drug: Valsartan/amlodipine |
| 3 | Active comparator | Drug: Amlodipine/hydrochlorothiazide(HCTZ) |
| 4 | Experimental | Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed as hypertensive
- Untreated confirmed hypertensive patients (consistent SBP >140 mm Hg or DBP >90 mm Hg)
- Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on one drug therapy.
- Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on two drug therapy.
Key exclusion criteria (8 listed)
- Inability to switch from all prior antihypertensive medications safely as required by the protocol.
- Need for drugs other than study drugs at the time of baseline.
- Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.
- Patients on four or more antihypertensive drugs at screening.
- Pregnant or nursing (lactating) women.
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 (HCTZ) | Drug | 1 |
| Valsartan/amlodipine | Drug | 2 |
| Amlodipine/hydrochlorothiazide(HCTZ) | Drug | 3 |
| Valsartan/amlodipine/hydrochlorothiazide(HCTZ) | Drug | 4 |
Primary outcome
Potential drug interaction and effect on blood level of drugs when co-administered for 17 days
1 secondary outcome
Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory
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 27 Sep 2010.
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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 principal investigator
Novartis investigative site
5 sites 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/hydrochlorothiazide (HCTZ), Valsartan/amlodipine and Amlodipine/hydrochlorothiazide(HCTZ) in people with Hypertension, run by Novartis at 5 sites in India.
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 8 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 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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?
Potential drug interaction and effect on blood level of drugs when co-administered for 17 days. 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 27 Sep 2010.