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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001998-25 | EudraCT Number | ||
| D-CAN-545 | Other Identifier | Takeda ID | |
| U1111-1113-9336 | Registry Identifier | WHO |
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The purpose of this study is to determine the efficacy of candesartan, once daily (QD), combined with hydrochlorothiazide to lower blood pressure in insulin-resistant, obese patients with hypertension.
Abdominal obesity is a major risk factor for insulin resistance and the development of type 2 diabetes. It is associated with sodium retention, left ventricular hypertrophy and elevated markers of inflammation and is an important predictor of cardiovascular morbidity and mortality. Activation of the sympathetic nervous system and the renin angiotensin aldosterone system are both involved in the development of hypertension in obese individuals. Hypertension in obese individuals is often associated with dyslipidemia, hyperinsulinaemia and impaired glucose tolerance.
In order to decrease the cardiovascular risk of obese hypertensive patients, therapy should not only be directed to lowering blood pressure values but also to improvement of their metabolic situation. As it is possible that antihypertensive treatment based on an angiotensin receptor antagonist (like candesartan) might be superior to beta-blocker or calcium channel blocker therapy in preventing diabetes, a combination of candesartan with already existing insufficiently effective beta-blocker or calcium channel blocker therapy will be used in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan + Hydrochlorothiazide QD | Experimental |
| |
| Hydrochlorothiazide QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan and Hydrochlorothiazide | Drug | Candesartan 8 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for 2 weeks; increased to Candesartan 16 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The change from Baseline in Blood pressure (mean reduction in Diastolic Blood Pressure measured at trough). | End of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The change from Baseline in Adiponectin. | At Final Visit. | |
| The change from Baseline in high sensitivity C-Reactive Protein. | At Final Visit. | |
| The change from Baseline in Fasting Plasma Glucose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda Pharma Gmbh, Aachen (Germany) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bad Dürrheim | Baden-Wurttemberg | Germany | ||||
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|
|
| Hydrochlorothiazide (HCT) | Drug | Candesartan placebo-matching tablets and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks. |
|
| At Final Visit. |
| The change from Baseline in Fasting Plasma Insulin. | At Final Visit. |
| The change from Baseline in Insulin Resistance (assessed by Homeostasis Model Assessment Insulin Resistance). | At Final Visit. |
| The change from Baseline in Lipid Parameters (total cholesterol, low-density lipoprotein cholesterol, high density lipoprotein cholesterol and triglycerides). | At Final Visit. |
| The change from Baseline in Fibrinogen. | At Final Visit. |
| The change from Baseline in Prospective Cardiovascular Münster risk score for the assessment of coronary heart disease. | At Final Visit. |
| The change from Baseline in 24-hour mean blood pressure as assessed by Ambulatory Blood Pressure Measurement. | At Final Visit. |
| The change from Baseline in Daytime and night-time mean blood pressure Ambulatory Blood Pressure Measurement. | At Final Visit. |
| The change from Baseline in Systolic Blood Pressure. | End of Treatment. |
| Balingen |
| Baden-Wurttemberg |
| Germany |
| Deggingen | Baden-Wurttemberg | Germany |
| Rottweil | Baden-Wurttemberg | Germany |
| Spaichingen | Baden-Wurttemberg | Germany |
| Ingolstadt | Bavaria | Germany |
| München | Bavaria | Germany |
| Passau | Bavaria | Germany |
| Schauenburg | Hesse | Germany |
| Bocholt | North Rhine-Westphalia | Germany |
| Cologne | North Rhine-Westphalia | Germany |
| Essen | North Rhine-Westphalia | Germany |
| Isselburg | North Rhine-Westphalia | Germany |
| Roetgen | North Rhine-Westphalia | Germany |
| Troisdorf | North Rhine-Westphalia | Germany |
| Wesseling | North Rhine-Westphalia | Germany |
| Rödersheim-Gronau | Rhineland-Palatinate | Germany |
| Dresden | Saxony | Germany |
| Freital | Saxony | Germany |
| Machem | Saxony | Germany |
| Markkleeberg | Saxony | Germany |
| Wermsdorf | Saxony | Germany |
| Bad Segeberg | Schleswig-Holstein | Germany |
| Berlin | State of Berlin | Germany |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D006973 | Hypertension |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C081643 | candesartan |
| D006852 | Hydrochlorothiazide |
| C077793 | candesartan cilexetil |
| 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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