Trial · NCT00699192
Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension
NCT00699192, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension. Trials, record NCT00699192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00699192
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension
- NCT number
- NCT00699192
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 965 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hypertension
- Interventions
- Amlodipine 5 mg, Valsartan 80 mg, Valsartan 40 mg, Placebo
- First posted
- 2008-06-17
- Last updated
- 2011-06-06
- Results first posted
- 2011-06-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP. |
| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP. |
| Secondary | Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8 | Baseline to end of study (Week 8) | A systolic blood pressure response was defined as a msSBP \< 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. |
| Secondary | Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | Systolic blood pressure control was defined as a msSBP \< 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. |
| Secondary | Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | Overall blood pressure control was defined as a msSBP \< 140 mmHg and msDBP \< 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the Week 8 assessments, an LOCF (last observation carried forward) approach was used. | mmHg | MEAN |
| SECONDARY | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used. | mmHg | MEAN |
| SECONDARY | Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8 | Baseline to end of study (Week 8) | The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Amlodipine/Valsartan 5/80 mg | -11.1 | Standard Deviation 12.68 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Amlodipine/Valsartan 5/40 mg | -12.3 | Standard Deviation 13.23 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Amlodipine 5 mg | -6.9 | Standard Deviation 14.00 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Amlodipine/Valsartan 5/80 mg | -4.2 | Standard Deviation 8.04 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Amlodipine/Valsartan 5/40 mg | -5.3 | Standard Deviation 8.19 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Amlodipine 5 mg | -1.7 | Standard Deviation 7.26 | mmHg | |
| Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8 | Amlodipine/Valsartan 5/80 mg | 46.0 | Percentage of patients | ||
| Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8 | Amlodipine/Valsartan 5/40 mg | 48.3 | Percentage of patients | ||
| Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8 | Amlodipine 5 mg | 34.0 | Percentage of patients | ||
| Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8) | Amlodipine/Valsartan 5/80 mg | 31.3 | Percentage of patients |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amlodipine/Valsartan 5/80 mg | 275 | |
| Overall Study | STARTED | Amlodipine/Valsartan 5/40 mg | 272 | |
| Overall Study | STARTED | Amlodipine 5 mg | 272 | |
| Overall Study | COMPLETED | Amlodipine/Valsartan 5/80 mg | 259 | |
| Overall Study | COMPLETED | Amlodipine/Valsartan 5/40 mg | 260 | |
| Overall Study | COMPLETED | Amlodipine 5 mg | 261 | |
| Overall Study | NOT COMPLETED | Amlodipine/Valsartan 5/80 mg | 16 | |
| Overall Study | NOT COMPLETED | Amlodipine/Valsartan 5/40 mg | 12 | |
| Overall Study | NOT COMPLETED | Amlodipine 5 mg | 11 |
Source ClinicalTrials.gov
Adverse events27
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 |
|---|---|---|---|---|---|---|
| serious | Angina pectoris | Cardiac disorders | Amlodipine/Valsartan 5/80 mg | 1 | 274 | |
| serious | Angina pectoris | Cardiac disorders | Amlodipine/Valsartan 5/40 mg | 0 | 272 | |
| serious | Angina pectoris | Cardiac disorders | Amlodipine 5 mg | 0 | 272 | |
| serious | Atrial fibrillation | Cardiac disorders | Amlodipine/Valsartan 5/80 mg | 1 | 274 | |
| serious | Atrial fibrillation | Cardiac disorders | Amlodipine/Valsartan 5/40 mg | 0 | 272 | |
| serious | Atrial fibrillation | Cardiac disorders | Amlodipine 5 mg | 0 | 272 | |
| serious | Tachyarrhythmia | Cardiac disorders | Amlodipine/Valsartan 5/80 mg | 0 | 274 | |
| serious | Tachyarrhythmia | Cardiac disorders | Amlodipine/Valsartan 5/40 mg | 0 | 272 | |
| serious | Tachyarrhythmia | Cardiac disorders | Amlodipine 5 mg | 1 | 272 | |
| serious | Ophthalmoplegia | Eye disorders | Amlodipine/Valsartan 5/80 mg | 0 | 274 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine/Valsartan 5/80 mg | ||
| Total, all-cause mortality | Amlodipine/Valsartan 5/40 mg | ||
| Total, all-cause mortality | Amlodipine 5 mg | ||
| Total, other adverse events | Amlodipine/Valsartan 5/80 mg | 0 | 274 |
| Total, other adverse events | Amlodipine/Valsartan 5/40 mg | 0 | 272 |
| Total, other adverse events | Amlodipine 5 mg | 0 | 272 |
| Total, serious adverse events | Amlodipine/Valsartan 5/80 mg | 5 | 274 |
| Total, serious adverse events | Amlodipine/Valsartan 5/40 mg | 2 | 272 |
| Total, serious adverse events | Amlodipine 5 mg | 1 | 272 |
Source ClinicalTrials.gov
Papers0
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00699192
GET https://conductscience.org/api/trials/v1/NCT00699192/events?page=2