Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe Hypertension

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Candesartan; Candesartan cilexetil; Hydrochlorothiazide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.