Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg

March 19, 2008 updated by: AstraZeneca

A Double Blind, Randomised, 3-Arm Parallel Group, Multicentre, 8-Week, Phase III Study to Assess Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) /HCT 32/12.5mg and 32/25mg vs. CC 32mg Alone in Patients With Inadequate BP Control on Monotherapy With CC 32mg

In this study it is intended to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1979

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Ballerup, Denmark
        • Research Site
      • Frederiksberg, Denmark
        • Research Site
      • Herlev, Denmark
        • Research Site
      • Kobenhavn, Denmark
        • Research Site
      • Vejle, Denmark
        • Research Site
  • Estonia
      • Parnu, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
      • Voru, Estonia
        • Research Site
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro
        • Research Site
      • Nis, Former Serbia and Montenegro
        • Research Site
      • Niska Banja, Former Serbia and Montenegro
        • Research Site
      • Sremska Kamenica, Former Serbia and Montenegro
        • Research Site
      • Zemun, Former Serbia and Montenegro
        • Research Site
  • France
      • Albens, France
        • Research Site
      • Arras, France
        • Research Site
      • Beziers, France
        • Research Site
      • Broglie, France
        • Research Site
      • Chartres, France
        • Research Site
      • Gemenos, France
        • Research Site
      • Hinx, France
        • Research Site
      • Husseren-wesserling, France
        • Research Site
      • Labarthe-sur-Leze, France
        • Research Site
      • Rosiers d'Egletons, France
        • Research Site
      • Seraincourt, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Tours, France
        • Research Site
      • Vourey, France
        • Research Site
  • Germany
      • Augsburg, Germany
        • Research Site
      • Bad Krozingen, Germany
        • Research Site
      • Bad Segeberg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Cloppenburg, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Erlangen, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Goch, Germany
        • Research Site
      • Grossheirath, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hann, Germany
        • Research Site
      • Hermaringen, Germany
        • Research Site
      • Herne, Germany
        • Research Site
      • Karlsruhe, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Kippenheim, Germany
        • Research Site
      • Koeln, Germany
        • Research Site
      • Kunzing, Germany
        • Research Site
      • Köln, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Nürnberg, Germany
        • Research Site
      • Riesa, Germany
        • Research Site
      • Rodgau-dudenhofen, Germany
        • Research Site
      • Schwerin, Germany
        • Research Site
      • Siegen, Germany
        • Research Site
      • Steinfurt, Germany
        • Research Site
      • Strasskirchen, Germany
        • Research Site
      • Tübingen, Germany
        • Research Site
      • Werne, Germany
        • Research Site
      • Witten, Germany
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
      • Klaipeda, Lithuania
        • Research Site
      • Panevezys, Lithuania
        • Research Site
      • Siauliai, Lithuania
        • Research Site
      • Vilnius, Lithuania
        • Research Site
  • Netherlands
      • Bennebroek, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Deurne, Netherlands
        • Research Site
      • Echt, Netherlands
        • Research Site
      • Ermelo, Netherlands
        • Research Site
      • Hengelo, Netherlands
        • Research Site
      • Hoogvliet, Netherlands
        • Research Site
      • Lichtenvoorde, Netherlands
        • Research Site
      • Losser, Netherlands
        • Research Site
      • Musselkanaal, Netherlands
        • Research Site
      • Oude Pekela, Netherlands
        • Research Site
      • Rijswijk, Netherlands
        • Research Site
      • Roelofarendsveen, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Volendam, Netherlands
        • Research Site
      • Woerden, Netherlands
        • Research Site
      • Zaandam, Netherlands
        • Research Site
      • s Hertogenbosch, Netherlands
        • Research Site
      • s-Gravenzande, Netherlands
        • Research Site
  • Poland
      • Chrzanow, Poland
        • Research Site
      • Elblag, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Gdynia, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Olawa, Poland
        • Research Site
      • Plock, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Skierniewice, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
  • Sweden
      • Boden, Sweden
        • Research Site
      • Gävle, Sweden
        • Research Site
      • Göteborg, Sweden
        • Research Site
      • Linköping, Sweden
        • Research Site
      • Malmö, Sweden
        • Research Site
      • Motala, Sweden
        • Research Site
      • Skellefteå, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Örebro, Sweden
        • Research Site
  • Ukraine
      • Chenoutsy, Ukraine
        • Research Site
      • Dnepropetrovsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kharkov, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
  • United Kingdom
      • Addlestone, United Kingdom
        • Research Site
      • Ashford, United Kingdom
        • Research Site
      • Ayrshire, United Kingdom
        • Research Site
      • Burbage, United Kingdom
        • Research Site
      • Cheadle, United Kingdom
        • Research Site
      • Chesterfield, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • ELY, United Kingdom
        • Research Site
      • Fife, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Harrow, United Kingdom
        • Research Site
      • Hastings, United Kingdom
        • Research Site
      • Helensburgh, United Kingdom
        • Research Site
      • Leamington Spa, United Kingdom
        • Research Site
      • Morriston, United Kingdom
        • Research Site
      • Motherwell, United Kingdom
        • Research Site
      • Newton Mearns, United Kingdom
        • Research Site
      • Northwood Middlesex, United Kingdom
        • Research Site
      • Paignton, United Kingdom
        • Research Site
      • Wokingham, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:
  • Provision of signed Informed Consent
  • Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs, which the patient and the physician are willing to withdraw at enrolment and change to candesartan monotherapy
  • Mean sitting DBP 90-114 mmHg
  • Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
  • Mean sitting DBP 90-114 mmHg on treatment with candesartan 32 mg monotherapy (after 2 weeks with candesartan 16 mg and 6 weeks with candesartan 32 mg monotherapy). The run-in period should not be shorter than 8 weeks.

Exclusion Criteria:

  • Involvement in the planning and conduct of the study (applies to both AstraZeneca staff, CRO staff or staff at the investigational centre)
  • Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant and verified by a negative pregnancy test at Visit 1
  • Secondary or malignant hypertension
  • Sitting SBP of 180 mmHg or more
  • Patients who are treated with candesartan 16 mg in combination with a diuretic or with candesartan 32 mg with or without any additional antihypertensive treatment
  • Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment
  • Angina pectoris requiring more treatment than short-acting nitrates
  • Chronic use of NSAIDs
  • Aortic or mitral valve stenosis
  • Cardiac failure requiring treatment
  • Cardiac arrhythmia requiring treatment
  • Gout
  • Renal artery stenosis or kidney transplantation
  • Intravascular volume depletion
  • Hypersensitivity to any component of the investigational products
  • Concomitant disease which may interfere with the assessment of the patient
  • Past or present alcohol or drug abuse, or any condition associated with poor compliance
  • Chronic liver disease or known liver enzyme values above three times the upper limit of the reference range for S-ASAT or S-ALAT
  • Concomitant or previous treatment with other investigational drugs within 20 days of enrolment
  • Previous enrolment in the present study
  • S-creatinine of 180 μmol/l or above for men and of 140 μmol/l or above for women
  • S-sodium or S-potassium outside the reference range
  • Less than 85% compliance with study medication during the run-in phase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Candesartan Cilexetil (CC) /HCT 32/12.5mg
Drug: Candesartan cilexetil
32mg oral
Other Names:
  • ATACAND
Drug: Hydrochlorothiazide
12.5 mg oral
Other Names:
  • HCTZ
Drug: Hydrochlorothiazide
25 mg oral
Other Names:
  • HCTZ
Experimental: 2
Candesartan Cilexetil (CC) /HCT 32/25mg
Drug: Candesartan cilexetil
32mg oral
Other Names:
  • ATACAND
Drug: Hydrochlorothiazide
12.5 mg oral
Other Names:
  • HCTZ
Drug: Hydrochlorothiazide
25 mg oral
Other Names:
  • HCTZ
Experimental: 3
Candesartan Cilexetil monotherapy
Drug: Candesartan cilexetil
32mg oral
Other Names:
  • ATACAND

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change (reduction) in sitting BP (24 hours after dose)
Time Frame: Assessed from baseline (randomisation) to the end of the study.
Assessed from baseline (randomisation) to the end of the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with controlled sitting BP in each treatment group
Time Frame: Assessed at the end of the study
Assessed at the end of the study
Occurrence of Adverse Events and discontinuation of study medication due to AEs from baseline (randomisation) to the end of the study
Time Frame: Assessed from baseline (randomisation) to the end of the study.
Assessed from baseline (randomisation) to the end of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Established Brands HTN/CHF Medical Sience Director, MD, AstraZeneca
  • Principal Investigator: Gerd Bonner, MD, MEDIAN Kliniken Bad Krozingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 3, 2006

First Submitted That Met QC Criteria

October 3, 2006

First Posted (Estimate)

October 4, 2006

Study Record Updates

Last Update Posted (Estimate)

March 20, 2008

Last Update Submitted That Met QC Criteria

March 19, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2456C00001
  • Eudract No. 2005-005718-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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