Trial · NCT01368536
Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes
NCT01368536, Phase 4, Terminated, Novartis Pharmaceuticals; results first posted 2013-03-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes. Trials, record NCT01368536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01368536
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes
- NCT number
- NCT01368536
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 975 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hypertension, Stage 2 Hypertension, Diabetes
- Interventions
- Valturna, Amlodipine, Chlorthalidone, Placebo of Valturna Tablet, Placebo Capsule
- First posted
- 2011-06-08
- Last updated
- 2013-03-21
- Results first posted
- 2013-03-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone | Baseline, 12 weeks | Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit. |
| Secondary | Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone | Baseline, 12 weeks | Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit. |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment | Baseline, 12 weeks | Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit. |
| Secondary | Percentage of Responders After Treatment | Baseline, 12 weeks | Responders are defined as patients with MSSBP \<130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg |
| Secondary | Percentage of Patients Achieving Blood Pressure Control After Treatment | 12 weeks | Patient with blood pressure control is defined as patients achieving MSSBP \<130 mmHg and MSDBP \<80 mmHg. |
| Secondary | Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | 12 weeks |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone | Baseline, 12 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone | Baseline, 12 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment | Baseline, 12 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Percentage of Responders After Treatment | Baseline, 12 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Percentage of Patients Achieving Blood Pressure Control After Treatment | 12 weeks | The study was terminated and consequentially was underpowered for adequate statistical analysis | ||
| SECONDARY | Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | 12 weeks | Safety Set - Consists of all patients who received at least one dose of the double-blind study drug. Patients were analyzed according to the treatment that they received. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna | Adverse Events | 62 | Participants | |
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna + Amlodipine | Adverse Events | 54 | Participants | |
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna + Chlorthalidone | Adverse Events | 58 | Participants | |
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna | Serious Adverse Events | 0 | Participants | |
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna + Amlodipine | Serious Adverse Events | 0 | Participants | |
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna + Chlorthalidone | Serious Adverse Events | 0 | Participants | |
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna | Death | 0 | Participants | |
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna + Amlodipine | Death | 0 | Participants | |
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone | Valturna + Chlorthalidone | Death | 0 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valturna | 138 | |
| Overall Study | STARTED | Valturna + Amlodipine | 137 | |
| Overall Study | STARTED | Valturna + Chlorthalidone | 142 | |
| Overall Study | Full Analysis Set | Valturna | 138 | |
| Overall Study | Full Analysis Set | Valturna + Amlodipine | 137 | |
| Overall Study | Full Analysis Set | Valturna + Chlorthalidone | 141 | |
| Overall Study | COMPLETED | Valturna | 87 | |
| Overall Study | COMPLETED | Valturna + Amlodipine | 78 | |
| Overall Study | COMPLETED | Valturna + Chlorthalidone | 83 | |
| Overall Study | NOT COMPLETED | Valturna | 51 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events9
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 | Diarrhoea | Gastrointestinal disorders | Valturna | 8 | 138 | |
| other | Diarrhoea | Gastrointestinal disorders | Valturna + Amlodipine | 4 | 137 | |
| other | Diarrhoea | Gastrointestinal disorders | Valturna + Chlorthalidone | 2 | 142 | |
| other | Dizziness | Nervous system disorders | Valturna | 3 | 138 | |
| other | Dizziness | Nervous system disorders | Valturna + Amlodipine | 4 | 137 | |
| other | Dizziness | Nervous system disorders | Valturna + Chlorthalidone | 11 | 142 | |
| other | Headache | Nervous system disorders | Valturna | 16 | 138 | |
| other | Headache | Nervous system disorders | Valturna + Amlodipine | 9 | 137 | |
| other | Headache | Nervous system disorders | Valturna + Chlorthalidone | 10 | 142 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valturna | ||
| Total, all-cause mortality | Valturna + Amlodipine | ||
| Total, all-cause mortality | Valturna + Chlorthalidone | ||
| Total, other adverse events | Valturna | 23 | 138 |
| Total, other adverse events | Valturna + Amlodipine | 16 | 137 |
| Total, other adverse events | Valturna + Chlorthalidone | 23 | 142 |
| Total, serious adverse events | Valturna | 0 | 138 |
| Total, serious adverse events | Valturna + Amlodipine | 0 | 137 |
| Total, serious adverse events | Valturna + Chlorthalidone | 0 | 142 |
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.
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/NCT01368536
GET https://conductscience.org/api/trials/v1/NCT01368536/registered