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| ID | Type | Description | Link |
|---|---|---|---|
| DE-CAN-027 | Other Identifier | Takeda ID | |
| 2009-011776-30 | EudraCT Number | ||
| U1111-1112-2376 | Registry Identifier | WHO |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan QD + Hydrochlorothiazide QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil and hydrochlorothiazide | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline and Week 9. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda Pharma GmbH (Germany) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | Germany | |||||
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| 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. | 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. | 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. | 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. | 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. | Baseline and Final Visit (up to Week 9) |
| Blankenhain |
| Germany |
| Dortmund | Germany |
| Hamburg | Germany |
| Köthen | Germany |
| Löhne | Germany |
| Nuremberg | Germany |
| Remscheid | Germany |
| Rodgau | Germany |
| Stockach | Germany |
| Wardenburg | Germany |
| Weinheim | Germany |
| Ivano-Frankivsk | Ukraine |
| Kharkiv | Ukraine |
| Kiev | Ukraine |
| Lviv | Ukraine |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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