HypertensionPhase 4NCT01012479
Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe Hypertension
A Phase 4 study testing Candesartan cilexetil and hydrochlorothiazide in people with Hypertension, run by Takeda at 16 sites in 2 countries.
Trial summary
The purpose of this study is to see if Candesartan, once daily (QD), added with Hydrochlorothiazide may be helpful in treating people with newly diagnosed severe essential hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Candesartan cilexetil and hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Oct 2009to Jun 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of essential hypertension.
- Has Systolic Blood Pressure between 150 mmHg and 200 mmHg AND Diastolic Blood Pressure between 110 mmHg and 120 mmHg.
- Has not received any antihypertensive treatment so far.
- Has a negative pregnancy test at baseline in females of childbearing potential. Male and female participants with reproductive potential must use an approved contraceptive method during study treatment evaluation
Who cannot join
- Has a known or suspected secondary hypertension or primary hyperaldosteronism.
- Has impaired renal function.
- Has severe hepatic impairment.
- Has bilateral renal artery stenosis, solitary kidney or post-renal transplant status.
- Has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention or cerebral accident (stroke or transient ischaemic attack) within the last 6 months.
- Has a diagnosis or suspicion of the following conditions: hypertrophic obstructive cardiomyopathy, angina pectoris, chronic heart failure, peripheral arterial occlusive disease, hypertensive retinopathy.
Show all 14Show fewer
- Has hemodynamically relevant stenosis of the aortic or mitral valve.
- Has clinically relevant and refractory hypokalaemia or hyperkalaemia.
- Has uncorrected volume or sodium depletion.
- Has gout or relevant hyperuricaemia.
- Has a known intolerance/hypersensitivity to Candesartan cilexetil or Hydrochlorothiazide.
- Has a known galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- Is taking psychotropic medication or is addicted to alcohol or drugs.
- Has participated in another trial of an investigational drug or a medical device within the last 30 days or is currently participating in another trial of an investigational drug or a medical device.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Germany12 sites
Study site
Berlin
Study site
Blankenhain
Study site
Dortmund
Study site
Hamburg
Study site
Köthen
Study site
Löhne
Study site
Nuremberg
Study site
Remscheid
Study site
Rodgau
Study site
Stockach
Study site
Wardenburg
Study site
Weinheim
Ukraine4 sites
Study site
Ivano-Frankivsk
Study site
Kharkiv
Study site
Kiev
Study site
Lviv
About this study
Official title: Clinical Study to Evaluate the Efficacy and Safety of the Combination Therapy Candesartan Cilexetil 32 mg Plus Hydrochlorothiazide 25 mg in Patients With Severe Hypertension
The purpose of this study is to see if Candesartan, once daily (QD), added with Hydrochlorothiazide may be helpful in treating people with newly diagnosed severe essential hypertension.
Read the detailed description
Medical data show a link between blood pressure and the risk of heart disease (cardiovascular disease) such as stroke and heart attack. Clinical trials have shown that lowering blood pressure in patients with high blood pressure (hypertension) reduces the number of cardiovascular events.
Many people still have untreated hypertension. There are many reasons why target blood pressure is not reached. One is that most patients need more than one antihypertensive drug in order to lower high blood pressure. Other reasons include poor patient compliance with taking their drugs.
Combining drugs that lower high blood pressure and have similar ways of working in the body may help high blood pressure and lower the risk for medication-related side effects. One of several drug combinations recommended for the treatment of high blood pressure is an angiotensin receptor blocker and a thiazide diuretic. Guidelines also note that combination tablets may improve patient compliance with taking their drugs.
Candesartan is an angiotensin type-1 receptor blocker. Hydrochlorothiazide is a diuretic with blood pressure-lowering effect. This study will combine both of these drugs in one pill and see how it works in people taking part in this study.
- Conditions
- Hypertension
- Being tested
- Candesartan cilexetil and hydrochlorothiazide
- Keywords
- Blood Pressure, Blood Pressure, High, Drug Therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan cilexetil and hydrochlorothiazideDrug
Also called Blopress, Atacand®, Amias, Ratacand
Candesartan cilexetil 16 mg, tablets, orally, once daily for 1 week; increased to candesartan cilexetil 16 mg and hydrochlorothiazide 12.5 mg combination tablet, orally once daily for 2 weeks; then increased to candesartan cilexetil 32 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for up to 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Candesartan QD + Hydrochlorothiazide QD | Experimental | Not described Receives: Drug: Candesartan cilexetil and hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Systolic Blood Pressure at Week 9.
The change between Systolic Blood Pressure (SBP) value collected at week 9 or final visit and SBP value collected at baseline
Measured: Baseline and Week 9.
Change from Baseline in Diastolic Blood Pressure at Week 9.
The change between Diastolic Blood Pressure (DBP) value collected at week 9 or final visit and DBP value collected at baseline.
Measured: Baseline and Week 9.
Secondary outcomes (6)
Percentage of subjects showing a decrease in SBP to less than 140 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to less than 90 mmHg and/or a decrease of DBP by at least 10 mmHg.
Percentage of participants at week 9 or final visit showing a decrease in SBP to less than 140 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to less than 90 mmHg and/or a decrease of DBP by at least 10 mmHg.
Measured: Week 9.
Percentage of subjects showing a decrease in SBP to less than 130 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to less than 80 mmHg and/or a decrease of DBP by at least 10 mmHg.
Percentage of participants at week 9 or final visit showing a decrease in SBP to less than 130 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to less than 80 mmHg and/or a decrease of DBP by at least 10 mmHg.
Measured: Week 9.
Change from Baseline in Pulse Rate at Week 9.
The change between Pulse Rate measured at week 9 and Pulse Rate measured at baseline.
Measured: Baseline and Week 9.
Change from Baseline in Systolic Blood Pressure at Final Visit.
The change between the Systolic Blood Pressure value collected at week 9 or final visit and the Systolic Blood Pressure value collected at baseline.
Measured: Baseline and Final Visit (up to Week 9)
Change in Baseline in Diastolic Blood Pressure at Final Visit.
The change between the Diastolic Blood Pressure value collected at week 9 or final visit and the Diastolic Blood Pressure value collected at baseline.
Measured: Baseline and Final Visit (up to Week 9)
Change from Baseline in Pulse Rate at Final Visit.
The change between Pulse Rate measured at week 9 or final visit and the Pulse Rate measured at baseline.
Measured: Baseline and Final Visit (up to Week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionJun 2010
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.
- More trials run by TakedaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Takeda Pharma GmbH (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012479
- Sponsor's protocol ID
- BLO K027
- Other IDs
- DE-CAN-027, 2009-011776-30, U1111-1112-2376, 2009
- Status last verified
- Jul 2010
- First submitted
- 12 Nov 2009
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy and Safety of the Combination Therapy Candesartan Cilexetil 32 mg Plus Hydrochlorothiazide 25 mg in Patients With Severe Hypertension
- ClinicalTrials.gov ID
- NCT01012479
- Acronym / sponsor ID
- BLO K027
- Conditions
- Hypertension
- Keywords
- Blood Pressure, Blood Pressure, High, Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Nov 2009 (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 see if Candesartan, once daily (QD), added with Hydrochlorothiazide may be helpful in treating people with newly diagnosed severe essential hypertension.
Detailed description
Medical data show a link between blood pressure and the risk of heart disease (cardiovascular disease) such as stroke and heart attack. Clinical trials have shown that lowering blood pressure in patients with high blood pressure (hypertension) reduces the number of cardiovascular events.
Many people still have untreated hypertension. There are many reasons why target blood pressure is not reached. One is that most patients need more than one antihypertensive drug in order to lower high blood pressure. Other reasons include poor patient compliance with taking their drugs.
Combining drugs that lower high blood pressure and have similar ways of working in the body may help high blood pressure and lower the risk for medication-related side effects. One of several drug combinations recommended for the treatment of high blood pressure is an angiotensin receptor blocker and a thiazide diuretic. Guidelines also note that combination tablets may improve patient compliance with taking their drugs.
Candesartan is an angiotensin type-1 receptor blocker. Hydrochlorothiazide is a diuretic with blood pressure-lowering effect. This study will combine both of these drugs in one pill and see how it works in people taking part in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candesartan QD + Hydrochlorothiazide QD | Experimental | Drug: Candesartan cilexetil and hydrochlorothiazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of essential hypertension.
- Has Systolic Blood Pressure between 150 mmHg and 200 mmHg AND Diastolic Blood Pressure between 110 mmHg and 120 mmHg.
- Has not received any antihypertensive treatment so far.
- Has a negative pregnancy test at baseline in females of childbearing potential. Male and female participants with reproductive potential must use an approved contraceptive method during study treatment evaluation
Key exclusion criteria (14 listed)
- Has a known or suspected secondary hypertension or primary hyperaldosteronism.
- Has impaired renal function.
- Has severe hepatic impairment.
- Has bilateral renal artery stenosis, solitary kidney or post-renal transplant status.
- Has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention or cerebral accident (stroke or transient ischaemic 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 |
|---|---|---|
| Candesartan cilexetil and hydrochlorothiazideAlso: Blopress, Atacand®, Amias, RatacandCandesartan cilexetil 16 mg, tablets, orally, once daily for 1 week; increased to candesartan cilexetil 16 mg and hydrochlorothiazide 12.5 mg combination tablet, orally once daily for 2 weeks; then increased to candesartan cilexetil 32 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for up to 6 weeks | Drug | Candesartan QD + Hydrochlorothiazide QD |
Primary outcome
Change from Baseline in Systolic Blood Pressure at Week 9.
Time frame: Baseline and Week 9.
The change between Systolic Blood Pressure (SBP) value collected at week 9 or final visit and SBP value collected at baseline
Change from Baseline in Diastolic Blood Pressure at Week 9.
Time frame: Baseline and Week 9.
The change between Diastolic Blood Pressure (DBP) value collected at week 9 or final visit and DBP value collected at baseline.
6 secondary outcomes
Percentage of subjects showing a decrease in SBP to less than 140 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to less than 90 mmHg and/or a decrease of DBP by at least 10 mmHg.
Time frame: Week 9.
Percentage of subjects showing a decrease in SBP to less than 130 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to less than 80 mmHg and/or a decrease of DBP by at least 10 mmHg.
Time frame: Week 9.
Change from Baseline in Pulse Rate at Week 9.
Time frame: Baseline and Week 9.
Change from Baseline in Systolic Blood Pressure at Final Visit.
Time frame: Baseline and Final Visit (up to Week 9)
Change in Baseline in Diastolic Blood Pressure at Final Visit.
Time frame: Baseline and Final Visit (up to Week 9)
Change from Baseline in Pulse Rate at Final Visit.
Time frame: Baseline and Final Visit (up to Week 9)
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 14 Jul 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.
Medical Director study director
Takeda Pharma GmbH (Germany)
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candesartan cilexetil and hydrochlorothiazide in people with Hypertension, run by Takeda at 16 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 4 inclusion and 14 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 14 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Ukraine. 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?
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 in Systolic Blood Pressure at Week 9. (time frame: Baseline and Week 9.). The study lists 2 primary outcomes in all. 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 14 Jul 2010.