Trial · NCT00434967
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
NCT00434967, Phase 3, Completed, AstraZeneca; results first posted 2009-06-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo. Trials, record NCT00434967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00434967
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
- NCT number
- NCT00434967
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,207 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hypertension
- Interventions
- Candesartan cilexetil, Hydrochlorothiazide, Candesartan/HCT 32/25 mg
- First posted
- 2007-02-14
- Last updated
- 2010-12-16
- Other registries' IDs
- eudract:2006-003963-30
- Results first posted
- 2009-06-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). | 8 weeks | Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline. |
| Primary | Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) | 8 weeks | Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline. |
| Secondary | The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study | 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 |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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). | Baseline to 8 weeks |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). | 8 weeks | mm Hg | LEAST_SQUARES_MEAN | |
| PRIMARY | Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) | 8 weeks | mm Hg | LEAST_SQUARES_MEAN | |
| SECONDARY | The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study | 8 weeks | participants | NUMBER | |
| SECONDARY | 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 | |||
| SECONDARY | 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 | |||
| SECONDARY | 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 | |||
| SECONDARY | 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 | |||
| SECONDARY | 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). | Baseline to 8 weeks |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). | Placebo | -3.3 | Standard Error 0.9 | mm Hg | |
| Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). | Candesartan 32 mg | -9.3 | Standard Error 0.4 | mm Hg | |
| Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). | HCT 25 mg | -7.7 | Standard Error 0.4 | mm Hg | |
| Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). | Candesartan/HCT 32/25 mg | -13.9 | Standard Error 0.4 | mm Hg | |
| Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) | Placebo | -3.7 | Standard Error 1.5 | mm Hg | |
| Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) | Candesartan 32 mg | -13.1 | Standard Error 0.7 | mm Hg | |
| Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) | HCT 25 mg | -11.6 | Standard Error 0.7 | mm Hg | |
| Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) | Candesartan/HCT 32/25 mg | -21.4 | Standard Error 0.6 | mm Hg | |
| The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study | Placebo | 8 | participants | ||
| The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study | Candesartan 32 mg | 198 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 97 | |
| Overall Study | STARTED | Candesartan 32 mg | 465 | |
| Overall Study | STARTED | HCT 25 mg | 470 | |
| Overall Study | STARTED | Candesartan/HCT 32/25 mg | 492 | |
| Overall Study | COMPLETED | Placebo | 90 | |
| Overall Study | COMPLETED | Candesartan 32 mg | 457 | |
| Overall Study | COMPLETED | HCT 25 mg | 461 | |
| Overall Study | COMPLETED | Candesartan/HCT 32/25 mg | 478 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Candesartan 32 mg | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Placebo | 0 | 97 | |
| other | Dizziness | Nervous system disorders | Candesartan 32 mg | 0 | 465 | |
| other | Dizziness | Nervous system disorders | HCT 25 mg | 0 | 470 | |
| other | Dizziness | Nervous system disorders | Candesartan/HCT 32/25 mg | 13 | 492 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 97 | |
| other | Headache | Nervous system disorders | Candesartan 32 mg | 18 | 465 | |
| other | Headache | Nervous system disorders | HCT 25 mg | 22 | 470 | |
| other | Headache | Nervous system disorders | Candesartan/HCT 32/25 mg | 10 | 492 | |
| other | Hypertension | Cardiac disorders | Placebo | 0 | 97 | |
| other | Hypertension | Cardiac disorders | Candesartan 32 mg | 10 | 465 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Candesartan 32 mg | ||
| Total, all-cause mortality | HCT 25 mg | ||
| Total, all-cause mortality | Candesartan/HCT 32/25 mg | ||
| Total, other adverse events | Placebo | 0 | |
| Total, other adverse events | Candesartan 32 mg | 38 | |
| Total, other adverse events | HCT 25 mg | 22 | |
| Total, other adverse events | Candesartan/HCT 32/25 mg | 23 | |
| Total, serious adverse events | Placebo | 2 | |
| Total, serious adverse events | Candesartan 32 mg | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00434967
GET https://conductscience.org/api/trials/v1/NCT00434967/events?page=2