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Completed

NCT Number: NCT00621153

Candesartan Effect in Second Stage Arterial Hypertension

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

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Key information

Conditions

Stage II Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Candesartan cilexetil

Drug

Candesartan Cilexetil 16 mg oral

Other names: Atacand

Hydrochlorothiazide

Drug

Hydrochlorothiazide 12.5 mg

Other names: HCTZ, Diazide

Primary outcomes

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

    Time frame: 4 weeks

    Mean of the changed DBP from baseline after 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

    Mean of the changed SBP from baseline after 4 weeks

  2. 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

    Time frame: 4 weeks

    Percent of the patients achieving goal DBP and SBP after 4 weeks

  3. 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

    Time frame: 8 weeks

    Percent of patients achieving goal of DBP

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

    Time frame: 8 weeks

    Changed SBP from baseline after 8 weeks

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

    Time frame: 8 weeks

    Change of hs-CRP from basline after 8 weeks

  6. Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks)

    Time frame: 8 weeks

    Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks

  7. Compliance Levels at 4 Weeks and 8 Weeks of Therapy

    Time frame: 8 weeks

    Percent of the number of returened pills to the number of prescrited pills

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Open-label, Randomised, 2-Arm Parallel Group, Multicentre, 8-week, Phase IV Study to Assess the Antihypertensive Efficacy and Safety of the Candesartan Cilexetil 16 mg and Hydrochlorothiazide 12.5 mg Combination Therapy in Comparison With Candesartan 16 mg Monotherapy in Hypertensive Adults

Acronym: CAESAR

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
Registry last updated
Mar 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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