Trial Outcomes & Findings for Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168) (NCT NCT00738972)
NCT ID: NCT00738972
Last Updated: 2013-08-26
Results Overview
Left ventricular hypertrophy reduction was to be measured by echocardiography.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
6 Month(s)
Results posted on
2013-08-26
Participant Flow
Participant milestones
| Measure |
Valsartan 80 mg + Paravastin 40 mg
Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
|
Valsartan 80 mg + Simvastatin 40 mg
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
|
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
|
Valsartan 80 mg
Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)
Baseline characteristics by cohort
| Measure |
Valsartan 80 mg + Paravastin 40 mg
n=3 Participants
Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
|
Valsartan 80 mg + Simvastatin 40 mg
n=3 Participants
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
|
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg
n=3 Participants
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
|
Valsartan 80 mg
n=2 Participants
Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
>18 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 Month(s)Population: This study was terminated early and due to sample size it was not possible to perform further statistical analyses.
Left ventricular hypertrophy reduction was to be measured by echocardiography.
Outcome measures
Outcome data not reported
Adverse Events
Valsartan 80 mg + Paravastin 40 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Valsartan 80 mg + Simvastatin 40 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Valsartan 80 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place