NCT00621153

Brief Summary

To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 23, 2010

Completed
Last Updated

March 23, 2010

Status Verified

April 1, 2009

Enrollment Period

1.1 years

First QC Date

January 24, 2008

Results QC Date

February 24, 2010

Last Update Submit

February 24, 2010

Conditions

Stage II Hypertension

Keywords

Candesartan Cilexetilhydrochlorothiazidesevere hypertension

Outcome Measures

Primary Outcomes (1)

  • Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy

    Mean of the changed DBP from baseline after 4 weeks

    4 weeks

Secondary Outcomes (7)

  • Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy

    4 weeks

  • Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy

    4 weeks

  • Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy

    8 weeks

  • Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy

    8 weeks

  • Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy

    8 weeks

  • +2 more secondary outcomes

Study Arms (4)

1

ACTIVE COMPARATOR

Candesartan cilexetil 16mg monotherapy

Drug: Candesartan Cilexetil

2

EXPERIMENTAL

Candesartan cilexetil 16mg/HCT combination therapy

Drug: Candesartan CilexetilDrug: Hydrochlorothiazide

3

ACTIVE COMPARATOR

candesartan cilexetil 32mg monotherapy

Drug: Candesartan Cilexetil

4

EXPERIMENTAL

Candesartan Cilexetil 32 mg/HCT combination therapy

Drug: HydrochlorothiazideDrug: Candesartan Cilexetil

Interventions

Candesartan CilexetilDRUG

Candesartan Cilexetil 16 mg oral

Also known as: Atacand
12
HydrochlorothiazideDRUG

Hydrochlorothiazide 12.5 mg

Also known as: HCTZ, Diazide
24

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs

You may not qualify if:

  • Current serum-creatinine \>3 mg/dL, Current serum-potassium \>5.5 mmol/L, 16.
  • Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Seoul, South Korea

Location

Related Publications (1)

  • Lee HY, Hong BK, Chung WJ, Lee BK, Lee SH, Jeon DW, Ahn YK, Kim D, Park CK, Kim SH, Jung HO, Kim BO, Choi D. Phase IV, 8-week, multicenter, randomized, active treatment-controlled, parallel group, efficacy, and tolerability study of high-dose candesartan cilexetil combined with hydrochlorothiazide in Korean adults with stage II hypertension. Clin Ther. 2011 Aug;33(8):1043-56. doi: 10.1016/j.clinthera.2011.07.002. Epub 2011 Aug 10.

    PMID: 21831438DERIVED

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
+44 1509 64589

Study Officials

  • Dong Hoon Choi

    Severance Hospital

    PRINCIPAL INVESTIGATOR

  • Joonwoo Bahn

    AstraZeneca Korea

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 22, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 23, 2010

Results First Posted

March 23, 2010

Record last verified: 2009-04

Locations

KR(1)