Trial Outcomes & Findings for 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 NCT01368536)
NCT ID: NCT01368536
Last Updated: 2013-03-21
Results Overview
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.
TERMINATED
PHASE4
975 participants
Baseline, 12 weeks
2013-03-21
Participant Flow
Of the 975 patients screened, 417 were randomized.
Participant milestones
| Measure |
Valturna
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
|
Valturna + Amlodipine
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
|
Valturna + Chlorthalidone
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
138
|
137
|
142
|
|
Overall Study
Full Analysis Set
|
138
|
137
|
141
|
|
Overall Study
COMPLETED
|
87
|
78
|
83
|
|
Overall Study
NOT COMPLETED
|
51
|
59
|
59
|
Reasons for withdrawal
| Measure |
Valturna
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
|
Valturna + Amlodipine
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
|
Valturna + Chlorthalidone
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
8
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
1
|
2
|
|
Overall Study
Abnormal test procedure result(s)
|
0
|
0
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
7
|
2
|
2
|
|
Overall Study
No longer required study medication
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
5
|
|
Overall Study
Administrative problems
|
34
|
39
|
35
|
|
Overall Study
Protocol deviation
|
0
|
3
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Valturna
n=138 Participants
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
|
Valturna + Amlodipine
n=137 Participants
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
|
Valturna + Chlorthalidone
n=141 Participants
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
54.7 Years
STANDARD_DEVIATION 8.65 • n=93 Participants
|
56.0 Years
STANDARD_DEVIATION 9.56 • n=4 Participants
|
54.6 Years
STANDARD_DEVIATION 9.35 • n=27 Participants
|
55.1 Years
STANDARD_DEVIATION 9.20 • n=483 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
216 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
200 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: The study was terminated and consequentially was underpowered for adequate statistical analysis
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The study was terminated and consequentially was underpowered for adequate statistical analysis
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The study was terminated and consequentially was underpowered for adequate statistical analysis
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The study was terminated and consequentially was underpowered for adequate statistical analysis
Responders are defined as patients with MSSBP \<130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: The study was terminated and consequentially was underpowered for adequate statistical analysis
Patient with blood pressure control is defined as patients achieving MSSBP \<130 mmHg and MSDBP \<80 mmHg.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Outcome measures
| Measure |
Valturna
n=138 Participants
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
|
Valturna + Amlodipine
n=137 Participants
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
|
Valturna + Chlorthalidone
n=142 Participants
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
|
|---|---|---|---|
|
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
Adverse Events
|
62 Participants
|
54 Participants
|
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
Serious Adverse Events
|
0 Participants
|
0 Participants
|
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
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Valturna
Valturna + Amlodipine
Valturna + Chlorthalidone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Valturna
n=138 participants at risk
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
|
Valturna + Amlodipine
n=137 participants at risk
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
|
Valturna + Chlorthalidone
n=142 participants at risk
At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
8/138
|
2.9%
4/137
|
1.4%
2/142
|
|
Nervous system disorders
Dizziness
|
2.2%
3/138
|
2.9%
4/137
|
7.7%
11/142
|
|
Nervous system disorders
Headache
|
11.6%
16/138
|
6.6%
9/137
|
7.0%
10/142
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER