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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
188
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.
Candesartan placebo-matching tablets and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.
Unnamed facility
Bad Dürrheim, Baden-Wurttemberg, Germany
Unnamed facility
Balingen, Baden-Wurttemberg, Germany
The change from Baseline in Blood pressure (mean reduction in Diastolic Blood Pressure measured at trough).
Time frame: End of Treatment
The change from Baseline in Adiponectin.
Time frame: At Final Visit.
The change from Baseline in high sensitivity C-Reactive Protein.
Time frame: At Final Visit.
The change from Baseline in Fasting Plasma Glucose.
Time frame: At Final Visit.
The change from Baseline in Fasting Plasma Insulin.
Time frame: At Final Visit.
The change from Baseline in Insulin Resistance (assessed by Homeostasis Model Assessment Insulin Resistance).
Time frame: At Final Visit.
The change from Baseline in Lipid Parameters (total cholesterol, low-density lipoprotein cholesterol, high density lipoprotein cholesterol and triglycerides).
Time frame: At Final Visit.
The change from Baseline in Fibrinogen.
Time frame: At Final Visit.
The change from Baseline in Prospective Cardiovascular Münster risk score for the assessment of coronary heart disease.
Time frame: At Final Visit.
The change from Baseline in 24-hour mean blood pressure as assessed by Ambulatory Blood Pressure Measurement.
Time frame: At Final Visit.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Deggingen, Baden-Wurttemberg, Germany
Unnamed facility
Rottweil, Baden-Wurttemberg, Germany
Unnamed facility
Spaichingen, Baden-Wurttemberg, Germany
Unnamed facility
Ingolstadt, Bavaria, Germany
Unnamed facility
München, Bavaria, Germany
Unnamed facility
Passau, Bavaria, Germany
Unnamed facility
Schauenburg, Hesse, Germany
Unnamed facility
Bocholt, North Rhine-Westphalia, Germany
...and 14 more locations
The change from Baseline in Daytime and night-time mean blood pressure Ambulatory Blood Pressure Measurement.
Time frame: At Final Visit.
The change from Baseline in Systolic Blood Pressure.
Time frame: End of Treatment.