NCT00434967

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,207

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Jan 2007

Geographic Reach
6 countries

27 active sites

Status
completed

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

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 17, 2009

Completed
Last Updated

December 16, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

February 13, 2007

Results QC Date

January 9, 2009

Last Update Submit

November 30, 2010

Conditions

Hypertension

Keywords

Blood pressure reductioncombination therapycandesartan cilexetilhydrochlorothiazide

Outcome Measures

Primary Outcomes (2)

  • Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 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)

    Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.

    8 weeks

Secondary Outcomes (6)

  • The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group 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).

    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.

    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.

    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).

    Baseline to 8 weeks

  • +1 more secondary outcomes

Study Arms (4)

4

NO INTERVENTION

Placebo

2

ACTIVE COMPARATOR

Candesartan cilexetil

Drug: Candesartan cilexetil

3

ACTIVE COMPARATOR

Hydrochlorothiazide (HCT)

Drug: Hydrochlorothiazide

1

EXPERIMENTAL

Candesartan cilexetil + Hydrochlorothiazide Combination

Drug: Candesartan cilexetilDrug: HydrochlorothiazideDrug: Candesartan/HCT 32/25 mg

Interventions

Candesartan cilexetilDRUG

32 mg oral tablet

Also known as: ATACAND
12
HydrochlorothiazideDRUG

25 mg oral tablet

Also known as: HCTZ
13
Candesartan/HCT 32/25 mgDRUG
1

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Dour, Belgium

Location

Research Site

Gozée, Belgium

Location

Research Site

Hasselt, Belgium

Location

Research Site

Linkebeek, Belgium

Location

Research Site

Marchovelette, Belgium

Location

Research Site

Ronquières, Belgium

Location

Research Site

Saint-Médard, Belgium

Location

Research Site

Steenokkerzel, Belgium

Location

Research Site

Daugavpils, Latvia

Location

Research Site

Ogre, Latvia

Location

Research Site

Riga, Latvia

Location

Research Site

Gozo, Malta

Location

Research Site

Gwardiamangia, Malta

Location

Research Site

Arad, Romania

Location

Research Site

Bucharest, Romania

Location

Research Site

Iași, Romania

Location

Research Site

Piteşti, Romania

Location

Research Site

Ploieşti, Romania

Location

Research Site

Târgovişte, Romania

Location

Research Site

Timișoara, Romania

Location

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Bratislava, Slovakia

Location

Research Site

Levice, Slovakia

Location

Research Site

Lučenec, Slovakia

Location

Research Site

Prešov, Slovakia

Location

Research Site

Šahy, Slovakia

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetilHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
AZTrial_Results_Posting@astrazeneca.com

Study Officials

  • Michael Klibaner, MD

    AstraZeneca

    STUDY DIRECTOR

  • Istvan Edes, MD

    DEOEC Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2007

First Posted

February 14, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 16, 2010

Results First Posted

June 17, 2009

Record last verified: 2010-11

Locations

RU(2)SL(5)BE(8)MA(2)RO(7)LA(3)