HypertensionPhase 4NCT00439738
Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
A Phase 4 study testing HCTZ + Amlodipine and Valsartan/HCTZ in people with Hypertension, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- HCTZ + Amlodipine and Valsartan/HCTZ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2006to Nov 2007
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age or older
- Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg
- Central (abdominal) obesity
Who cannot join
- Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg
- Currently taking more then 3 medications to treat high blood pressure
- Inability to stop all current blood pressure medications if any up to 4 weeks
- History of Type 1 or Type 2 diabetes
- History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months
- History of or current diagnosis of congestive heart failure
Show all 10Show fewer
- History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma
- Women who are pregnant or nursing
- Alcohol or drug abuse within the last 2 years
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northeast Tarrant Internal Medicine Assoc
Euless, Texas, 76040
Terence T. Hart, MD
Muscle Shoals, Alabama, 35662
Oklahoma Cardiovascular & Hypertension
Oklahoma City, Oklahoma, 73132
Frandsen Family Medicine
Port Orchard, Washington, 98366
Westlake Medical Research
Westlake Village, California, 91361
About this study
Official title: A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients
The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.
- Conditions
- Hypertension
- Being tested
- HCTZ + Amlodipine, Valsartan/HCTZ
- Keywords
- Obesity, hypertension, valsartan/hydrochlorothiazide
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCTZ + AmlodipineDrug
- 12.5 mg HCTZ capsules
- 25 mg HCTZ capsules
- 5 mg amlodipine capsules
- 10 mg amlodipine capsules
Valsartan/HCTZDrug
- 160 mg film-coated valsartan tablets
- 320 mg film-coated valsartan tablets
- 12.5 mg HCTZ capsules
- 25 mg HCTZ capsules
| Study group | Role | What they receive |
|---|---|---|
| valsartan/HCTZ | Experimental | Not described Receives: Drug: Valsartan/HCTZ |
| HCTZ +Amlodipine | Active comparator | Not described Receives: Drug: HCTZ + Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Sitting Systolic Blood Pressure (MSSBP)
Measured: Baseline to Week 8
Secondary outcomes (6)
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Measured: Baseline to Weeks 4, 8, 12 and 16
Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg
Measured: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg
Measured: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)
Change From Baseline in Postprandial Glucose
After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Measured: Week 16
Change From Baseline in Postprandial Insulin
After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Measured: Week 16
Change From Baseline in Postprandial Non-esterified Fatty Acids
After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionNov 2007
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 (3)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439738
- Sponsor's protocol ID
- CVAH631BUS06
- Status last verified
- Apr 2017
- First submitted
- 23 Feb 2007
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Deedwania PC, Zappe DH, Egan BM, Purkayastha D, Samuel R, Sowers JR. Does response of RAS blockade on serum K+ levels influence its glycemic-mitigating response when combined with hydrochlorothiazide? J Clin Hypertens (Greenwich). 2012 Jul;14(7):415-21. doi: 10.1111/j.1751-7176.2012.00635.x. Epub 2012 Apr 26.
PubMed 22747613Ofili EO, Zappe DH, Purkayastha D, Samuel R, Sowers JR. Antihypertensive and metabolic effects of Angiotensin receptor blocker/diuretic combination therapy in obese, hypertensive African American and white patients. Am J Ther. 2013 Jan;20(1):2-12. doi: 10.1097/MJT.0b013e318230ae66.
PubMed 22248871Sowers JR, Raij L, Jialal I, Egan BM, Ofili EO, Samuel R, Zappe DH, Purkayastha D, Deedwania PC. Angiotensin receptor blocker/diuretic combination preserves insulin responses in obese hypertensives. J Hypertens. 2010 Aug;28(8):1761-9. doi: 10.1097/HJH.0b013e32833af380.
PubMed 20498618
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00439738
- Acronym / sponsor ID
- CVAH631BUS06
- Conditions
- Hypertension
- Keywords
- Obesity, hypertension, valsartan/hydrochlorothiazide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Nov 2007 (actual)
- First posted
- 26 Feb 2007 (estimated)
- Results
- Posted 10 Feb 2009
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 compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| valsartan/HCTZ | Experimental | Drug: Valsartan/HCTZ |
| HCTZ +Amlodipine | Active comparator | Drug: HCTZ + Amlodipine |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years of age or older
- Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg
- Central (abdominal) obesity
Key exclusion criteria (10 listed)
- Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg
- Currently taking more then 3 medications to treat high blood pressure
- Inability to stop all current blood pressure medications if any up to 4 weeks
- History of Type 1 or Type 2 diabetes
- History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months
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 |
|---|---|---|
| HCTZ + Amlodipine* 12.5 mg HCTZ capsules * 25 mg HCTZ capsules * 5 mg amlodipine capsules * 10 mg amlodipine capsules | Drug | HCTZ +Amlodipine |
| Valsartan/HCTZ* 160 mg film-coated valsartan tablets * 320 mg film-coated valsartan tablets * 12.5 mg HCTZ capsules * 25 mg HCTZ capsules | Drug | valsartan/HCTZ |
Primary outcome
Change in Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame: Baseline to Week 8
6 secondary outcomes
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: Baseline to Weeks 4, 8, 12 and 16
Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
Time frame: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
Time frame: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)
Change From Baseline in Postprandial Glucose
Time frame: Week 16
Change From Baseline in Postprandial Insulin
Time frame: Week 16
Change From Baseline in Postprandial Non-esterified Fatty Acids
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22747613Deedwania PC, Zappe DH, Egan BM, Purkayastha D, Samuel R, Sowers JR. Does response of RAS blockade on serum K+ levels influence its glycemic-mitigating response when combined with hydrochlorothiazide? J Clin Hypertens (Greenwich). 2012 Jul;14(7):415-21. doi: 10.1111/j.1751-7176.2012.00635.x. Epub 2012 Apr 26.
- Derived from this study: PubMed 22248871Ofili EO, Zappe DH, Purkayastha D, Samuel R, Sowers JR. Antihypertensive and metabolic effects of Angiotensin receptor blocker/diuretic combination therapy in obese, hypertensive African American and white patients. Am J Ther. 2013 Jan;20(1):2-12. doi: 10.1097/MJT.0b013e318230ae66.
- Derived from this study: PubMed 20498618Sowers JR, Raij L, Jialal I, Egan BM, Ofili EO, Samuel R, Zappe DH, Purkayastha D, Deedwania PC. Angiotensin receptor blocker/diuretic combination preserves insulin responses in obese hypertensives. J Hypertens. 2010 Aug;28(8):1761-9. doi: 10.1097/HJH.0b013e32833af380.
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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 chair
Novartis Pharmaceuticals
5 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 HCTZ + Amlodipine and Valsartan/HCTZ in people with Hypertension, run by Novartis Pharmaceuticals at 5 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 3 inclusion and 10 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 16 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 5 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 10 Feb 2009). 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 in Mean Sitting Systolic Blood Pressure (MSSBP) (time frame: Baseline to Week 8). 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 NCT00439738, which also lists 3 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 16 May 2017.