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

NCT ID: NCT01012479

Last Updated: 2010-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-06-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Candesartan QD + Hydrochlorothiazide QD

Group Type: EXPERIMENTAL

Candesartan cilexetil and hydrochlorothiazide

Intervention Type: 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

Interventions

Candesartan cilexetil and hydrochlorothiazide

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

Intervention Type: DRUG

Other Intervention Names

Blopress; Atacand®; Amias; Ratacand; Kenzen; Blopressid

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Takeda Pharma GmbH, Aachen (Germany)

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda Pharma GmbH (Germany)

Locations

Berlin, , Germany

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

Countries

Germany; Ukraine

Other Identifiers

DE-CAN-027

Identifier Type: OTHER

Identifier Source: secondary_id

2009-011776-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1112-2376

Identifier Type: REGISTRY

Identifier Source: secondary_id

BLO K027

Identifier Type: -

Identifier Source: org_study_id