Trial · NCT00902304
Valsartan Intensified Primary Care Reduction of Blood Pressure Study
NCT00902304, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2012-08-30
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ConductScience Library. Valsartan Intensified Primary Care Reduction of Blood Pressure Study. Trials, record NCT00902304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00902304
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Valsartan Intensified Primary Care Reduction of Blood Pressure Study
- NCT number
- NCT00902304
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,337 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hypertension
- Interventions
- Valsartan and hydrochlorothiazide (HCTZ) - monotherapy, Valsartan and amlodipine, Usual care, Valsartan, Valsartan and hydrochlorothiazide (HCTZ) - combination arm
- First posted
- 2009-05-15
- Last updated
- 2012-12-04
- Results first posted
- 2012-08-30
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | 26 weeks | BP target groups were: \<= 125/75mmHg, \<= 130/80mmHg and \<= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines. |
| Secondary | Change in Mean Sitting Systolic Blood Pressure | Baseline and 26 weeks | The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization. |
| Secondary | Change in Mean Sitting Diastolic Blood Pressure | Baseline and 26 weeks | The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization. |
| Secondary | Change in Absolute Cardiovascular Risk Score | Baseline and 26 weeks | The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of \<10% is a low risk, 10 to 15% is a moderate risk, and \>15% is a high risk. A decrease indicates improvement. |
| Secondary | Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy | 26 weeks | The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset. |
| Secondary | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | 26 weeks | A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg. |
| Secondary | Change in the EQ-5D Score | Baseline and 26 weeks | The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement. |
| Secondary | Number of Patients With Depression | Baseline and week 26 | Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions. |
| Secondary | Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26 | Baseline and week 26 | The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression. The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression. |
| Secondary | Participants With End Organ Disease at Baseline and Week 26 | Baseline and week 26 | A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio \> 30mg/mol or 24h urine protein \> 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio \> 25mg/mol(male) or \>35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values \>= 38mm). Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage. It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis. | percentage of participants | NUMBER |
| SECONDARY | Change in Mean Sitting Systolic Blood Pressure | Baseline and 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Sitting Diastolic Blood Pressure | Baseline and 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Absolute Cardiovascular Risk Score | Baseline and 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | percentage risk score change | MEAN |
| SECONDARY | Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy | 26 weeks | Safety analysis - consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment. | participants | NUMBER |
| SECONDARY | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. | Participants | NUMBER |
| SECONDARY | Change in the EQ-5D Score | Baseline and 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | change in EQ-5D score | MEAN |
| SECONDARY | Number of Patients With Depression | Baseline and week 26 | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | participants | NUMBER |
| SECONDARY | Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26 | Baseline and week 26 | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | change in CES-D score | MEAN |
| SECONDARY | Participants With End Organ Disease at Baseline and Week 26 | Baseline and week 26 | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. | participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | Usual Care | 27.4 | percentage of participants | ||
| Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | Monotherapy (Initial Monotherapy Arm) | 33.0 | percentage of participants | ||
| Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | Combination (Initial Combination Therapy Arm) | 37.9 | percentage of participants | ||
| Change in Mean Sitting Systolic Blood Pressure | Usual Care | -10 | 95% Confidence Interval -11.3 to -8.8 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure | Monotherapy (Initial Monotherapy Arm) | -11.6 | 95% Confidence Interval -13.1 to -10.0 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure | Combination (Initial Combination Therapy Arm) | -14.4 | 95% Confidence Interval -15.5 to -13.2 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure | Usual Care | -5.45 | 95% Confidence Interval -6.2 to -4.7 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure | Monotherapy (Initial Monotherapy Arm) | -6.9 | 95% Confidence Interval -7.9 to -5.9 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure | Combination (Initial Combination Therapy Arm) | -8.29 | 95% Confidence Interval -9.0 to -7.6 | mmHg | |
| Change in Absolute Cardiovascular Risk Score | Usual Care | -2.6 | Standard Deviation 4.5 | percentage risk score change |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Usual Care | 524 | |
| Overall Study | STARTED | Monotherapy (Initial Monotherapy Arm) | 360 | |
| Overall Study | STARTED | Combination (Initial Combination Therapy Arm) | 678 | |
| Overall Study | COMPLETED | Usual Care | 466 | |
| Overall Study | COMPLETED | Monotherapy (Initial Monotherapy Arm) | 289 | |
| Overall Study | COMPLETED | Combination (Initial Combination Therapy Arm) | 568 | |
| Overall Study | NOT COMPLETED | Usual Care | 58 | |
| Overall Study | NOT COMPLETED | Monotherapy (Initial Monotherapy Arm) | 71 | |
| Overall Study | NOT COMPLETED | Combination (Initial Combination Therapy Arm) | 110 |
Source ClinicalTrials.gov
Adverse events360
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 | Cardiac disorders | Pre-randomization | 77 | 2,185 | |
| other | Dizziness | Cardiac disorders | Usual Care | 23 | 524 | |
| other | Dizziness | Cardiac disorders | Monotherapy (Initial Monotherapy Arm) | 28 | 360 | |
| other | Dizziness | Cardiac disorders | Combination (Initial Combination Therapy Arm) | 42 | 678 | |
| other | Oedema peripheral | General disorders | Pre-randomization | 20 | 2,185 | |
| other | Oedema peripheral | General disorders | Usual Care | 27 | 524 | |
| other | Oedema peripheral | General disorders | Monotherapy (Initial Monotherapy Arm) | 9 | 360 | |
| other | Oedema peripheral | General disorders | Combination (Initial Combination Therapy Arm) | 67 | 678 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | Pre-randomization | 0 | 2,185 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | Usual Care | 1 | 524 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-randomization | ||
| Total, all-cause mortality | Usual Care | ||
| Total, all-cause mortality | Monotherapy (Initial Monotherapy Arm) | ||
| Total, all-cause mortality | Combination (Initial Combination Therapy Arm) | ||
| Total, other adverse events | Pre-randomization | 95 | 2,185 |
| Total, other adverse events | Usual Care | 47 | 524 |
| Total, other adverse events | Monotherapy (Initial Monotherapy Arm) | 36 | 360 |
| Total, other adverse events | Combination (Initial Combination Therapy Arm) | 105 | 678 |
| Total, serious adverse events | Pre-randomization | 27 | 2,185 |
| Total, serious adverse events | Usual Care | 24 | 524 |
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/NCT00902304
GET https://conductscience.org/api/trials/v1/NCT00902304/results?page=2