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Trial record 40 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial (NOAAH)

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: NCT01030458
Recruitment Status : Completed
First Posted : December 11, 2009
Results First Posted : November 15, 2013
Last Update Posted : December 9, 2013
Sponsor:
Collaborators:
University of Kinshasa
Yaounde Central Hospital
University of Yaounde
University of Libreville
Institute of Cardiology Abidjan
University of Ilorin Teaching Hospital
University of Nigeria, Enugu Campus
Hospital Aristide Le Dantec, Dakar, Senegal
Information provided by (Responsible Party):
Jan A. Staessen, KU Leuven

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Blood Pressure
Interventions Drug: amlodipine 5/10 mg per day plus valsartan 160 mg/day
Drug: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
Enrollment 183
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Hide Arm/Group Description In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months. In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
Period Title: Overall Study
Started 94 89
Completed 67 57
Not Completed 27 32
Reason Not Completed
Lost to Follow-up             9             10
Withdrawal by Subject             2             3
Logistical reasons             9             5
Moved or changed job             6             13
Side effect of medication             1             1
Arm/Group Title Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol Total
Hide Arm/Group Description In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan. In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol Total of all reporting groups
Overall Number of Baseline Participants 94 89 183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 89 participants 183 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
89
  94.7%
82
  92.1%
171
  93.4%
>=65 years
5
   5.3%
7
   7.9%
12
   6.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 89 participants 183 participants
51.3  (9.3) 51.2  (8.7) 51.2  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 89 participants 183 participants
Female
53
  56.4%
43
  48.3%
96
  52.5%
Male
41
  43.6%
46
  51.7%
87
  47.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 89 participants 183 participants
Nigeria 46 46 92
Senegal 20 20 40
Gabon 6 2 8
Cameroon 22 21 43
1.Primary Outcome
Title Sitting Systolic Blood Pressure on Automated Measurement
Hide Description Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.
Time Frame 6 months follow-up after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle.
Arm/Group Title Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Hide Arm/Group Description:
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
Overall Number of Participants Analyzed 94 89
Mean (Standard Deviation)
Unit of Measure: mmHg
127.2  (10.7) 134.1  (13.1)
2.Secondary Outcome
Title Time to Blood Pressure Control
Hide Description The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.
Time Frame 6 months follow-up after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Hide Arm/Group Description:
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
Overall Number of Participants Analyzed 94 89
Median (Inter-Quartile Range)
Unit of Measure: weeks
12
(4 to 20)
18
(4 to 24)
3.Secondary Outcome
Title Side-effects to Study Medications
Hide Description [Not Specified]
Time Frame 6 months follow-up after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Hide Arm/Group Description:
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
Overall Number of Participants Analyzed 94 89
Measure Type: Number
Unit of Measure: participants
1 1
4.Secondary Outcome
Title Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up
Hide Description This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic)
Time Frame 6 months follow-up after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Hide Arm/Group Description:
In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
Overall Number of Participants Analyzed 94 89
Measure Type: Number
Unit of Measure: participants
58 40
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Hide Arm/Group Description In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan. In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
All-Cause Mortality
Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/94 (0.00%)      0/89 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Amlodipine Plus Valsartan Hydrochlorothiazide Plus Bisoprolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/94 (1.06%)      1/89 (1.12%)    
General disorders     
Bilateral leg oedema  1/94 (1.06%)  1 0/89 (0.00%)  0
Nervous system disorders     
Insomnia/asthenia  0/94 (0.00%)  0 1/89 (1.12%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Prof. Dr. Jan A Staessen
Organization: University of Leuven
Phone: +32 16 34 7104
EMail: jan.staessen@med.kuleuven.be
Layout table for additonal information
Responsible Party: Jan A. Staessen, KU Leuven
ClinicalTrials.gov Identifier: NCT01030458     History of Changes
Other Study ID Numbers: NOAAH version 5.0.2
First Submitted: December 9, 2009
First Posted: December 11, 2009
Results First Submitted: July 9, 2013
Results First Posted: November 15, 2013
Last Update Posted: December 9, 2013