Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 99 for:    AMLODIPINE AND VALSARTAN

Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00439738
Recruitment Status : Completed
First Posted : February 26, 2007
Results First Posted : February 10, 2009
Last Update Posted : May 16, 2017
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: HCTZ + Amlodipine
Drug: Valsartan/HCTZ
Enrollment 412
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 206 206
Completed 170 178
Not Completed 36 28
Reason Not Completed
Withdrawal by Subject             16             13
Adverse Event             6             4
Lost to Follow-up             5             6
Protocol Violation             6             3
Lack of Efficacy             2             2
Abnormal Lab Values             1             0
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 206 206 412
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 206 participants 206 participants 412 participants
< 65 years 172 180 352
>=65 years 34 26 60
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 206 participants 412 participants
Female
124
  60.2%
148
  71.8%
272
  66.0%
Male
82
  39.8%
58
  28.2%
140
  34.0%
1.Primary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (MSSBP)
Hide Description [Not Specified]
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT), Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 197 204
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 159.7  (7.81) 159.0  (7.62)
Week 8 131.2  (16.26) 137.5  (13.52)
Change from baseline -28.6  (15.61) -21.5  (12.58)
2.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Hide Description [Not Specified]
Time Frame Baseline to Weeks 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT), Last Observation Carried Forward (LOCF)
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 197 204
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 94.9  (7.94) 93.6  (8.18)
Week 4 85.7  (9.38) 87.6  (9.20)
Week 8 81.9  (9.87) 85.1  (8.54)
Week 12 81.1  (9.14) 82.8  (8.75)
Week 16 80.8  (10.14) 80.9  (8.66)
Change from baseline to week 16 -14.0  (9.90) -12.7  (8.35)
3.Secondary Outcome
Title Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
Hide Description Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg
Time Frame Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT)
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 197 204
Measure Type: Number
Unit of Measure: participants
Week 4 91 69
Week 8 123 102
Week 12 122 112
Week 16 124 140
End of study 133 146
4.Secondary Outcome
Title Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
Hide Description Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg
Time Frame Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT)
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 197 204
Measure Type: Number
Unit of Measure: participants
Week 4 33 18
Week 8 59 23
Week 12 57 46
Week 16 62 65
End of Study 68 68
5.Secondary Outcome
Title Change From Baseline in Postprandial Glucose
Hide Description After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Only those patients who completed the study through week 16 were included in this analysis.
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 197 204
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline visit (0 minutes) 98.0  (15.91) 99.4  (19.12)
Week 16 (0 minutes) 98.1  (15.68) 102.8  (17.81)
Change from baseline to week 16 (0 minutes) -0.5  (13.71) 3.4  (18.28)
Baseline visit (120 minutes) 123.9  (47.18) 127.7  (40.30)
Week 16 (120 minutes) 126.3  (49.52) 146.5  (56.51)
Change from baseline to week 16 (120 minutes) 2.1  (38.21) 18.9  (40.88)
6.Secondary Outcome
Title Change From Baseline in Postprandial Insulin
Hide Description After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Only those patients who completed the study through week 16 were included in this analysis
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 197 204
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline visit (0 minutes) 19.66  (20.435) 20.37  (20.583)
Week 16 (0 minutes) 23.45  (26.039) 23.62  (19.267)
Change from baseline to week 16 (0 minutes) 3.41  (28.427) 3.67  (19.170)
Baseline visit (120 minutes) 92.04  (82.183) 95.95  (76.483)
Week 16 (120 minutes) 116.04  (129.880) 120.01  (100.302)
Change from baseline to week 16 (120 minute) 24.68  (90.094) 28.07  (71.674)
7.Secondary Outcome
Title Change From Baseline in Postprandial Non-esterified Fatty Acids
Hide Description After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Only those patients who completed the study through week 16 were included in this analysis
Arm/Group Title Valsartan/HCTZ (Hydrochlorothiazide) HCTZ +Amlodipine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 197 204
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline visit (0 minutes) 0.45  (0.208) 0.47  (0.318)
Week 16 (0 minutes) 0.46  (0.194) 0.47  (0.196)
Change from baseline to week 16 (0 minutes) 0.01  (0.249) 0.00  (0.341)
Baseline visit (120 minutes) 0.11  (0.090) 0.10  (0.116)
Week 16 (120 minutes) 0.10  (0.093) 0.10  (0.056)
Change from baseline to week 16 (120 minutes) -0.01  (0.117) -0.01  (0.120)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 1-862-778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00439738     History of Changes
Other Study ID Numbers: CVAH631BUS06
First Submitted: February 23, 2007
First Posted: February 26, 2007
Results First Submitted: November 5, 2008
Results First Posted: February 10, 2009
Last Update Posted: May 16, 2017