Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe Hypertension - Full Text View

Sponsor:	Takeda Pharma GmbH
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT01012479

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Candesartan cilexetil and hydrochlorothiazide	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Study to Evaluate the Efficacy and Safety of the Combination Therapy Candesartan Cilexetil 32 mg Plus Hydrochlorothiazide 25 mg in Patients With Severe Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Candesartan Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Change from Baseline in Systolic Blood Pressure at Week 9. [ Time Frame: Baseline and Week 9. ] [ Designated as safety issue: No ]
The change between Systolic Blood Pressure (SBP) value collected at week 9 or final visit and SBP value collected at baseline
Change from Baseline in Diastolic Blood Pressure at Week 9. [ Time Frame: Baseline and Week 9. ] [ Designated as safety issue: No ]
The change between Diastolic Blood Pressure (DBP) value collected at week 9 or final visit and DBP value collected at baseline.

Secondary Outcome Measures:

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. [ Time Frame: Week 9. ] [ Designated as safety issue: No ]
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.
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. [ Time Frame: Week 9. ] [ Designated as safety issue: No ]
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.
Change from Baseline in Pulse Rate at Week 9. [ Time Frame: Baseline and Week 9. ] [ Designated as safety issue: No ]
The change between Pulse Rate measured at week 9 and Pulse Rate measured at baseline.
Change from Baseline in Systolic Blood Pressure at Final Visit. [ Time Frame: Baseline and Final Visit (up to Week 9) ] [ Designated as safety issue: No ]
The change between the Systolic Blood Pressure value collected at week 9 or final visit and the Systolic Blood Pressure value collected at baseline.
Change in Baseline in Diastolic Blood Pressure at Final Visit. [ Time Frame: Baseline and Final Visit (up to Week 9) ] [ Designated as safety issue: No ]
The change between the Diastolic Blood Pressure value collected at week 9 or final visit and the Diastolic Blood Pressure value collected at baseline.
Change from Baseline in Pulse Rate at Final Visit. [ Time Frame: Baseline and Final Visit (up to Week 9) ] [ Designated as safety issue: No ]
The change between Pulse Rate measured at week 9 or final visit and the Pulse Rate measured at baseline.

Enrollment:	107
Study Start Date:	October 2009
Study Completion Date:	June 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Candesartan QD + Hydrochlorothiazide QD	Drug: 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 Other Names: Blopress Atacand® Amias Ratacand Kenzen Blopressid

Arms

Assigned Interventions

Experimental: Candesartan QD + Hydrochlorothiazide QD

Drug: 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

Other Names:

Blopress
Atacand®
Amias
Ratacand
Kenzen
Blopressid

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012479

Locations

Germany

Berlin, Germany

Blankenhain, Germany

Dortmund, Germany

Hamburg, Germany

Köthen, Germany

Löhne, Germany

Nürnberg, Germany

Remscheid, Germany

Rodgau, Germany

Stockach, Germany

Wardenburg, Germany

Weinheim, Germany
Ukraine

Ivano-Frankivsk, Ukraine

Kharkiv, Ukraine

Kiev, Ukraine

Lviv, Ukraine

Sponsors and Collaborators

Takeda Pharma GmbH

Investigators

Study Director:

Medical Director

Takeda Pharma GmbH (Germany)

More Information

No publications provided

Responsible Party:	Medical Director, Takeda Pharma GmbH, Aachen (Germany)
ClinicalTrials.gov Identifier:	NCT01012479 History of Changes
Other Study ID Numbers:	BLO K027, DE-CAN-027, 2009-011776-30, U1111-1112-2376
Study First Received:	November 12, 2009
Last Updated:	July 12, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Ukraine: Ministry of Health

Keywords provided by Takeda Global Research & Development Center, Inc.:

Blood Pressure
Blood Pressure, High
Drug Therapy

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Candesartan cilexetil
Candesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2012