Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo

November 30, 2010 updated by: AstraZeneca

A Double-blind, Randomised, 4-arm Parallel Group, Multicentre, 8-week, Phase III Study to Assess the Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) 32 mg and Hydrochlorothiazide (HCT) 25 mg Compared With CC 32 mg, HCT 25 mg and Placebo in Hypertensive Adults

The aim is to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32 mg alone, HCT 25 mg alone and placebo in hypertensive adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2207

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

  • Belgium
      • Dour, Belgium
        • Research Site
      • Gozée, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Linkebeek, Belgium
        • Research Site
      • Marchovelette, Belgium
        • Research Site
      • Ronquières, Belgium
        • Research Site
      • Saint-Médard, Belgium
        • Research Site
      • Steenokkerzel, Belgium
        • Research Site
  • Latvia
      • Daugavpils, Latvia
        • Research Site
      • Ogre, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
  • Malta
      • Gozo, Malta
        • Research Site
      • Gwardiamangia, Malta
        • Research Site
  • Romania
      • Arad, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Pitesti, Romania
        • Research Site
      • Ploiesti, Romania
        • Research Site
      • Targoviste, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Levice, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Sahy, Slovakia
        • 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

20 years to 80 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 (substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo.
  • Mean sitting DBP 90-114 mmHg (value calculated in the eCRF) at Visits 1 and 2
  • Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
  • Mean sitting DBP of 90-114 mmHg (value calculated in the eCRF) at the end of the 4-week single-blind placebo run-in period. The run-in period should not be shorter than 4 weeks.

Exclusion Criteria:

  • Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant. Pregnancy must be excluded by a negative pregnancy test at Visit 1.
  • Secondary or malignant hypertension
  • Sitting SBP of 180 mmHg or more
  • 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 or to any sulphonamide derived drugs
  • 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 that in the opinion of the investigator might affect the patient's participation in the study
  • Chronic liver disease
  • Concomitant or previous treatment with any other investigational drug within 20 days of enrolment
  • Previous enrolment in the present study

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 4
Placebo
ACTIVE_COMPARATOR: 2
Candesartan cilexetil
Drug: Candesartan cilexetil
32 mg oral tablet
Other Names:
  • ATACAND
ACTIVE_COMPARATOR: 3
Hydrochlorothiazide (HCT)
Drug: Hydrochlorothiazide
25 mg oral tablet
Other Names:
  • HCTZ
EXPERIMENTAL: 1
Candesartan cilexetil + Hydrochlorothiazide Combination
Drug: Candesartan cilexetil
32 mg oral tablet
Other Names:
  • ATACAND
Drug: Hydrochlorothiazide
25 mg oral tablet
Other Names:
  • HCTZ
Drug: Candesartan/HCT 32/25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).
Time Frame: 8 weeks
Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.
8 weeks
Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)
Time Frame: 8 weeks
Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study
Time Frame: 8 weeks
Controlled sitting SBP and sitting DBP are defined as having sitting SBP < 140 mmHg and sitting DBP < 90 mmHg at the end of the study
8 weeks
Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).
Time Frame: Baseline to 8 weeks
Baseline to 8 weeks
To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.
Time Frame: Baseline to 8 weeks
Baseline to 8 weeks
To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP.
Time Frame: Baseline to 8 weeks
Baseline to 8 weeks
To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study).
Time Frame: Baseline to 8 weeks
Baseline to 8 weeks
To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study).
Time Frame: Baseline to 8 weeks
Baseline to 8 weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Michael Klibaner, MD, AstraZeneca
  • Principal Investigator: Istvan Edes, MD, DEOEC Institute of Cardiology

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

January 1, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

February 13, 2007

First Submitted That Met QC Criteria

February 13, 2007

First Posted (ESTIMATE)

February 14, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2456C00002
  • EudraCT No. 2006-003963-30

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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