Efficacy and Safety of Candesartan Cilexetil Plus Hydrochlorothiazide in Subjects With Severe Hypertension
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
4 other identifiers
interventional
107
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
Started Oct 2009
Shorter than P25 for phase_4 hypertension
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 14, 2010
July 1, 2010
7 months
November 12, 2009
July 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Systolic Blood Pressure at Week 9.
The change between Systolic Blood Pressure (SBP) value collected at week 9 or final visit and SBP value collected at baseline
Baseline and Week 9.
Change from Baseline in Diastolic Blood Pressure at Week 9.
The change between Diastolic Blood Pressure (DBP) value collected at week 9 or final visit and DBP value collected at baseline.
Baseline and Week 9.
Secondary Outcomes (6)
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.
Week 9.
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.
Week 9.
Change from Baseline in Pulse Rate at Week 9.
Baseline and Week 9.
Change from Baseline in Systolic Blood Pressure at Final Visit.
Baseline and Final Visit (up to Week 9)
Change in Baseline in Diastolic Blood Pressure at Final Visit.
Baseline and Final Visit (up to Week 9)
- +1 more secondary outcomes
Study Arms (1)
Candesartan QD + Hydrochlorothiazide QD
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (16)
Unknown Facility
Berlin, Germany
Unknown Facility
Blankenhain, Germany
Unknown Facility
Dortmund, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Köthen, Germany
Unknown Facility
Löhne, Germany
Unknown Facility
Nuremberg, Germany
Unknown Facility
Remscheid, Germany
Unknown Facility
Rodgau, Germany
Unknown Facility
Stockach, Germany
Unknown Facility
Wardenburg, Germany
Unknown Facility
Weinheim, Germany
Unknown Facility
Ivano-Frankivsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Kiev, Ukraine
Unknown Facility
Lviv, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda Pharma GmbH (Germany)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 13, 2009
Study Start
October 1, 2009
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
July 14, 2010
Record last verified: 2010-07