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Trial record 16 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

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: NCT00698646
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : December 15, 2010
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Valsartan + HCTZ
Drug: Valsartan
Drug: HCTZ
Enrollment 384
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valsartan HCTZ Valsartan + HCTZ
Hide Arm/Group Description At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12 At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
Period Title: Overall Study
Started 128 128 128
Completed 92 97 99
Not Completed 36 31 29
Reason Not Completed
Adverse Event             8             7             8
Unsatisfactory Therapeutic Effect             11             11             7
Protocol Deviation             6             2             3
Withdrawal by Subject             10             11             8
Lost to Follow-up             0             0             2
Administrative problems             1             0             1
Arm/Group Title Valsartan HCTZ Valsartan + HCTZ Total
Hide Arm/Group Description At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12 At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. Total of all reporting groups
Overall Number of Baseline Participants 128 128 128 384
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 128 participants 128 participants 384 participants
77.7  (4.22) 77.7  (4.80) 77.2  (3.99) 77.5  (4.34)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 128 participants 384 participants
70-75 years 41 41 44 126
76-80 years 60 56 65 181
>80 years 27 31 19 77
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 128 participants 384 participants
Female
81
  63.3%
62
  48.4%
71
  55.5%
214
  55.7%
Male
47
  36.7%
66
  51.6%
57
  44.5%
170
  44.3%
1.Primary Outcome
Title Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward
Arm/Group Title Valsartan HCTZ Valsartan + HCTZ
Hide Arm/Group Description:
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
Overall Number of Participants Analyzed 128 126 126
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 166.2  (11.07) 164.5  (11.84) 164.5  (11.86)
Week 4 157.5  (19.71) 150.9  (18.41) 147.1  (18.35)
Change in MSSBP from Baseline to Week 4 -8.6  (19.47) -13.6  (16.81) -17.3  (17.61)
2.Secondary Outcome
Title Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Hide Description [Not Specified]
Time Frame Baseline and Weeks 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward
Arm/Group Title Valsartan HCTZ Valsartan + HCTZ
Hide Arm/Group Description:
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
Overall Number of Participants Analyzed 128 126 126
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 84.9  (9.78) 85.5  (9.09) 84.8  (9.36)
Week 4 81.0  (10.61) 81.6  (10.97) 77.8  (9.66)
Change in MSDBP from Baseline to Week 4 -3.9  (9.08) -3.9  (10.24) -7.1  (8.80)
Week 8 78.3  (10.33) 79.1  (11.97) 76.5  (9.45)
Change in MSDBP from Baseline to Week 8 -6.6  (10.26) -6.4  (10.72) -8.4  (9.68)
Week 12 77.6  (11.0) 78.1  (11.42) 75.4  (8.87)
Change in MSDBP from Baseline to Week 12 -7.3  (10.55) -7.3  (10.75) -9.5  (9.66)
Week 16 77.8  (10.34) 77.9  (11.66) 76.6  (8.42)
Change in MSDBP from Baseline to Week 16 -7.1  (10.78) -7.5  (10.76) -8.3  (8.62)
3.Secondary Outcome
Title Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Hide Description [Not Specified]
Time Frame Baseline and Weeks 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT), Last observation carried forward
Arm/Group Title Valsartan HCTZ Valsartan + HCTZ
Hide Arm/Group Description:
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
Overall Number of Participants Analyzed 128 126 126
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 166.2  (11.07) 164.5  (11.84) 164.5  (11.86)
Week 8 150.4  (20.29) 147.4  (18.69) 144.2  (19.93)
Change in MSSBP from Baseline to Week 8 -15.7  (20.43) -17.1  (17.83) -20.2  (19.12)
Week 12 148.6  (21.45) 145.1  (19.38) 142.0  (18.78)
Change in MSSBP from Baseline to Week 12 -17.5  (21.16) -19.4  (19.19) -22.5  (19.52)
Week 16 148.7  (20.06) 144.9  (19.59) 143.5  (18.69)
Change in MSSBP from Baseline to Week 16 -17.5  (19.62) -19.7  (19.69) -20.9  (18.49)
4.Secondary Outcome
Title Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
Hide Description Cumulative refers to achieving of blood pressure control before or at the corresponding visit.
Time Frame Weeks 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT)
Arm/Group Title Valsartan HCTZ Valsartan + HCTZ
Hide Arm/Group Description:
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
Overall Number of Participants Analyzed 128 126 126
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 25 37.3 49.21
Week 8 40.63 50.79 63.49
Week 12 50 61.11 69.05
Week 16 55.47 66.67 72.22
5.Secondary Outcome
Title Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
Hide Description Cumulative refers to achieving blood pressure goal before or at the corresponding visit.
Time Frame Weeks 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT)
Arm/Group Title Valsartan HCTZ Valsartan + HCTZ
Hide Arm/Group Description:
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
Overall Number of Participants Analyzed 128 126 126
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 25 38.89 49.21
Week 8 40.63 52.38 63.49
Week 12 50 62.70 69.05
Week 16 56.25 68.25 72.22
6.Secondary Outcome
Title Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])
Hide Description [Not Specified]
Time Frame During 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT)
Arm/Group Title Valsartan HCTZ Valsartan + HCTZ
Hide Arm/Group Description:
At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
Overall Number of Participants Analyzed 128 126 126
Median (95% Confidence Interval)
Unit of Measure: Weeks
12.0
(8.0 to 12.0)
8.0
(7.0 to 12.0)
4.0
(3.0 to 8.0)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valsartan + HCTZ HCTZ Valsartan
Hide Arm/Group Description At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
All-Cause Mortality
Valsartan + HCTZ HCTZ Valsartan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Valsartan + HCTZ HCTZ Valsartan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/128 (2.34%)   4/128 (3.13%)   3/128 (2.34%) 
Cardiac disorders       
Atrial fibrillation  1  0/128 (0.00%)  1/128 (0.78%)  0/128 (0.00%) 
Gastrointestinal disorders       
Gastric ulcer haemorrhage  1  0/128 (0.00%)  0/128 (0.00%)  1/128 (0.78%) 
Infections and infestations       
Appendicitis  1  0/128 (0.00%)  0/128 (0.00%)  1/128 (0.78%) 
Pneumonia  1  1/128 (0.78%)  0/128 (0.00%)  0/128 (0.00%) 
Injury, poisoning and procedural complications       
Clavicle fracture  1  0/128 (0.00%)  0/128 (0.00%)  1/128 (0.78%) 
Spinal fracture  1  0/128 (0.00%)  0/128 (0.00%)  1/128 (0.78%) 
Thoracic vertebral fracture  1  0/128 (0.00%)  1/128 (0.78%)  0/128 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung cancer metastatic  1  1/128 (0.78%)  0/128 (0.00%)  0/128 (0.00%) 
Nervous system disorders       
Cerebral haemorrhage  1  0/128 (0.00%)  0/128 (0.00%)  1/128 (0.78%) 
Syncope  1  1/128 (0.78%)  1/128 (0.78%)  0/128 (0.00%) 
Transient ischaemic attack  1  0/128 (0.00%)  1/128 (0.78%)  0/128 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/128 (0.78%)  0/128 (0.00%)  0/128 (0.00%) 
Vascular disorders       
Hypotension  1  1/128 (0.78%)  0/128 (0.00%)  0/128 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valsartan + HCTZ HCTZ Valsartan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/128 (12.50%)   27/128 (21.09%)   23/128 (17.97%) 
General disorders       
Fatigue  1  5/128 (3.91%)  10/128 (7.81%)  5/128 (3.91%) 
Infections and infestations       
Upper respiratory tract infection  1  1/128 (0.78%)  4/128 (3.13%)  8/128 (6.25%) 
Nervous system disorders       
Dizziness  1  5/128 (3.91%)  8/128 (6.25%)  9/128 (7.03%) 
Headache  1  6/128 (4.69%)  9/128 (7.03%)  3/128 (2.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00698646    
Other Study ID Numbers: CVAH631BUS08
First Submitted: June 13, 2008
First Posted: June 17, 2008
Results First Submitted: November 16, 2010
Results First Posted: December 15, 2010
Last Update Posted: April 19, 2011